They represent over 1,500 hospitals and one-third of all U. S. hospital beds. Civica has also begun to supply the U. S. Department of Veteran’s Affairs, the U. S. Department of Defense and the U. S. Strategic National Stockpile of essential medicines. Civica recently announced plans to expand its mission, via a unit called Civica Script, to into the outpatient shop space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market.
The availability of Civica’s affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life
sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications. Civica’s mission is to ensure that quality generic medications are accessible and affordable to everyone.
Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients. ” Civica’s manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway. To find out more about how Civica’s innovative model is directly impacting patient care, click
here to read a summary from the New England Journal of Medicine. ( catalyst.
nejm. org/doi/full/10.1056/CAT.21.0189 ) To learn more about Civica’s plans to bring affordable insulin to Americans living with diabetes, click here to read an article in Bio Space. ( /article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/ ) Job Description: This individual has accountability to manage and deliver affordable drug substance, drug product, and API from Civica’s contract development and manufacturing partners (CDMO) in India and Asia Pacific region. The primary role is to actively manage manufacturing, operational, and quality performance according to those agreements during startup, tech transfer, and commercial phases.
For new products and supply nodes, this individual will partner with Civica Business development, Quality, and Executive Leadership to identify and secure agreements with potential partners in the region for biologics, retail, and hospital products, and lead due diligence efforts. As Civica partners increase over time, this individual may be required to staff a small team of consultants/contingent workers to support local quality, engineering, and subject matter experts during intense phases of startup. This may include tech transfer or Health Authority Inspection readiness.
Essential Duties and Responsibilities: For startup phase, act as Civica Operations counterpart to CMO Leadership, and person-in-plant support (PIP) for critical startup activities, always advocating for on time delivery of quality medicines in the best interest of patients and Civica. Facilitate communication of Civica deliverables in support of the Manufacturing Service Agreement such as demand planning. Ensure the CDMO delivers commitments based on Civica Supply Chain planning requirements. Proactively identify risks to supply based upon ongoing trend performance.
These risks can often only be detected through periodic on-site visits. Work with CDMO project management and Civica program management to build tech transfer and startup schedules, and carefully manage schedule adherence. Participate with Civica Supply Chain in Quarterly supplier reviews. For startup sites, work directly with general management and staff to recommend and implement operational improvements. Ensure CDMO is operating within the agreed Quality agreement. Coordinate QA support resources with Civica quality to enable audit and supplier qualification. Prioritize resources at the CDMO, and within Civica to ensure critical products are released in a timely manner.
Ensure CDMO site master plans and major capital upgrades are executed according to agreements and within the best interest of Civica products. Basic Qualifications and Capabilities: 14 years minimum experience, 5 of which should be in a plant operations environment. Experience in Quality and Operations organizations within GMP manufacturing BS/BA level collegiate degree from accredited university Requires up to 50% travel to partner CDMO’s, however time outside of travel can be conducted as remotely-design.
They represent over 1,500 hospitals and one-third of all U. S. hospital beds. Civica has also begun to supply the U. S. Department of Veteran’s Affairs, the U. S. Department of Defense and the U. S. Strategic National Stockpile of essential medicines. Civica recently announced plans to expand its mission, via a unit called Civica Script, to into the outpatient shop space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market.
The availability of Civica’s affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life
sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications. Civica’s mission is to ensure that quality generic medications are accessible and affordable to everyone.
Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients. ” Civica’s manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway. To find out more about how Civica’s innovative model is directly impacting patient care, click
here to read a summary from the New England Journal of Medicine. ( catalyst.
nejm. org/doi/full/10.1056/CAT.21.0189 ) To learn more about Civica’s plans to bring affordable insulin to Americans living with diabetes, click here to read an article in Bio Space. ( /article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/ ) Position Summary Advanced level Manufacturing Technician position with the responsibility to weigh and dispense active medical ingredients (API) and excipients in preparation of compounding. Compound bulk solutions for the filling operations and operate packaging equipment. Essential Duties and Responsibilities Under the Manufacturing Lead and/or Supervisor’s direction, support manufacturing operations to meet strategic department objectives.
Prepare cleaning and sanitizing solutions and perform daily, weekly, monthly cleaning of controlled and classified manufacturing areas. Replenish manufacturing components, materials, and supplies in all processing areas. Transport bright stock and finished product to and from staging as required according to manufacturing schedule. Perform equipment cleaning and preparation for sterilization. Operate sterilizer equipment to provide format parts for filling equipment. Clean, set up, and decontaminate material transfer isolator.
Clean, set up, and operate component processing equipment. Clean, set up, and operate terminal sterilizer equipment. Clean, set up, and operate weighing and compounding equipment. Weigh APIs and excipients according to batch record instructions. Compound bulk drug product per standard operating procedures and batch record instructions. Clean, set up, and operate packaging equipment. Adhere to Civica procedures and policies, conform to current good manufacturing practices and good documentation practices. Adhere to all safety regulations. Attend and participate in daily shift meetings to communicate events and issues to the manufacturing team.
Perform other duties as assigned by manufacturing management. Minimum Qualifications (Knowledge, Skills, and Abilities) • High school diploma or equivalent. Coursework or bachelor’s degree in a Life Science discipline preferred. • 2-3 years’ experience in medical manufacturing environment preferred. • Good reading and writing skills, and ability to perform basic to advanced mathematical calculations. • Ability to read, understand and follow written procedures.
They represent over 1,500 hospitals and one-third of all U. S. hospital beds. Civica has also begun to supply the U. S. Department of Veteran’s Affairs, the U. S. Department of Defense and the U. S. Strategic National Stockpile of essential medicines. Civica recently announced plans to expand its mission, via a unit called Civica Script, to into the outpatient shop space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market.
The availability of Civica’s affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life
sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications. Civica’s mission is to ensure that quality generic medications are accessible and affordable to everyone.
Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients. ” Civica’s manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway. To find out more about how Civica’s innovative model is directly impacting patient care, click
here to read a summary from the New England Journal of Medicine. ( catalyst.
nejm. org/doi/full/10.1056/CAT.21.0189 ) To learn more about Civica’s plans to bring affordable insulin to Americans living with diabetes, click here to read an article in Bio Space. ( /article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/ ) Job Description: The Head of Quality Systems leads the deployment and improvement of the Quality Management System (QMS) at Civica that ensures a high state of c GMP compliance and supports the effective execution of Civica objectives, including lifecycle management of policies and procedures for processes that govern all Gx P related activities.
Also, leads the following quality management systems: Documentation, Change Management, Investigation/Deviation and CAPA, Complaints, IT Quality, and Training. Additionally, is the owner of Electronic Systems associated with Documentation Management, Deviations/CAPA Management, Change Management and Learning Management. Essential Duties and Responsibilities: Establish, and maintain the global QMS elements including policies, processes, procedures and controls, enabling successful and efficient development and manufacturing of drug products meeting Civica and regulatory requirements.
Establish and maintain risk-based, fit-for-purpose Quality Management System. Oversee the pharmacovigilance program ensuring robust reporting and investigations. Responsible for the electronic quality management system (VEEVA) and ensuring the system maintains its validated state. Develop robust systems to assure corrective and preventive measures are systematically implemented and controlled. Propose and drive continuous improvements to the Quality Management System to streamline business processes and stay in compliance with external requirements (e. g. regulatory). Design and maintain trending program for quality events/ laboratory controls/ production controls by key indicators (e.
g. dates, categories, root causes, and CAPA) to identify adverse trends/ risk to help drive continuous improvement for manufacturing/ production controls and laboratory controls per Civica Gx P procedures. Ensure Computer System Validation (CSV) processes are fully implemented with the appropriate quality oversight. Develop and implement Medical Device Reporting (MDR) processes for combination products. Support and ensure the governance of any other initiatives as delegated. Establish and maintain Quality Plan.
Basic Qualifications and Capabilities: Minimum 15 years of life science/medical/biologics product manufacturing and development experience. Bachelor’s degree in a science, shop, or engineering discipline. Advanced degree desired. Broad knowledge and experience with quality assurance and quality system, regulatory compliance and understanding of current regulatory requirements and trends for manufacturing drug substance, drug product and combination products, in particular sterile injectable medications. Prior experience managing personnel. Working knowledge of software solutions for QMS.
Strong personal performance combined with demonstrated ability to build and lead highly engaged teams in a high growth environment. Strong project management skills with an emphasis on critical thinking and problem solving. Demonstrated ability to apply risk-based approaches to Quality Systems implementation, and maintenance. Extensive experience in hosting FDA inspections, keeping pace with ongoing updated regulations and requirements, and as applicable especially 21CFR211, 21CFR820/803/806.
They represent over 1,500 hospitals and one-third of all U. S. hospital beds. Civica has also begun to supply the U. S. Department of Veteran’s Affairs, the U. S. Department of Defense and the U. S. Strategic National Stockpile of essential medicines. Civica recently announced plans to expand its mission, via a unit called Civica Script, to into the outpatient shop space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market.
The availability of Civica’s affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life
sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications. Civica’s mission is to ensure that quality generic medications are accessible and affordable to everyone.
Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients. ” Civica’s manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway. To find out more about how Civica’s innovative model is directly impacting patient care, click
here to read a summary from the New England Journal of Medicine. ( catalyst.
nejm. org/doi/full/10.1056/CAT.21.0189 ) To learn more about Civica’s plans to bring affordable insulin to Americans living with diabetes, click here to read an article in Bio Space. ( /article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/ ) Position Summary Entry Level position with the responsibility to maintain the manufacturing areas in a clean and orderly state, and to provide manufacturing lines with the required components, materials, and supplies. Essential Duties and Responsibilities Under the Manufacturing Lead and/or Supervisor’s direction, support manufacturing operations to meet strategic department objectives.
Prepare cleaning and sanitizing solutions and perform daily, weekly, monthly cleaning of controlled and classified manufacturing areas. Replenish manufacturing components, materials, and supplies in all processing areas. Transport bright stock and finished product to and from staging as required according to manufacturing schedule. Adhere to Civica procedures and policies, conform to current good manufacturing practices and good documentation practices. Adhere to all safety regulations. Attend and participate in daily shift meetings to communicate events and issues to the manufacturing team.
Perform other duties as assigned by manufacturing management. Minimum Qualifications (Knowledge, Skills, and Abilities) High school diploma or equivalent. Experience in any manufacturing environment preferred.
from within culture. Allied Universal Janitorial Services is seeking the position of a Maintenance Technician. Pay rate 16.00 / Hour As a Maintenance Technician for Allied Universal Janitorial Services, you will be responsible for performing routine electrical, mechanical, plumbing, HVAC, architectural features/finishes and systems' maintenance for the facility to the client's standards.
The Technician will also approach work with a " safety first" attitude by following all safety practices, policies, and procedures, promoting safe working conditions, and ensuring the proper maintenance and organization of all equipment; make arrangements for repair and/or replacement of used
and damaged equipment to avoid service disruptions. Qualifications/Requirements Be at least 18 years of age with high school diploma or equivalent for full time positions.
Certain positions may require successful completion of a background investigation and a drug screen in accordance with all federal, state, and local laws. Effective communication skills with customer, patrons, and employees- assisting others in a friendly and engaging manner at all times. Knowledge of cleaning chemicals and supplies. A proactive approach in anticipating, listening to, understanding, and responding to customer needs Experience providing quality maintenance services in all trades - HVAC, electrical, plumbing,
carpentry. Read and interpret schematics and building plans and have strong electrical background Knowledge of OSHA and safety standards for maintenance programs.
Possess basic computer proficiency. Strong attention to detail and reliability on completing tasks that can be repetitive. Able to: Work in various working conditions and environments such as cold weather, rain/snow or heat for extended periods. Ability to operate various cleaning equipment and machinery including scrubbers, pressure washer, and carpet extractor. Ability to climb ladders, stand or walk on various surfaces for long periods of time. Ability to lift and carry items and/or machinery up to 50 pounds.
Ability to grab, twist, bend, stoop, kneel, reach overhead, and operate equipment frequently and repetitively during working hours. Allied Universal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race/ethnicity, age, color, religion, interaction, interactionual orientation, gender identity, national origin, genetic information, disability, protected veteran status or relationship/association with a protected veteran, or any other basis or characteristic protected by law. For more information: If you have any questions regarding Equal Employment Opportunity, Affirmative Action, Diversity and Inclusion, have difficulty using the online system and require an alternate method to apply, or require an accommodation at any time during the recruitment and/or employment process, please contact our local Human Resources department.
To find an office near you, please visit: /offices.
They represent over 1,500 hospitals and one-third of all U. S. hospital beds. Civica has also begun to supply the U. S. Department of Veteran’s Affairs, the U. S. Department of Defense and the U. S. Strategic National Stockpile of essential medicines. Civica recently announced plans to expand its mission, via a unit called Civica Script, to into the outpatient shop space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market.
The availability of Civica’s affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life
sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications. Civica’s mission is to ensure that quality generic medications are accessible and affordable to everyone.
Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients. ” Civica’s manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway. To find out more about how Civica’s innovative model is directly impacting patient care, click
here to read a summary from the New England Journal of Medicine. ( catalyst.
nejm. org/doi/full/10.1056/CAT.21.0189 ) To learn more about Civica’s plans to bring affordable insulin to Americans living with diabetes, click here to read an article in Bio Space. ( /article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/ ) Job Purpose As a member of the Engineering and Technical Services Automation Team, the successful candidate will be required to support complex and challenging system automation initiatives that require solid understanding of analytical problem-solving techniques, project management, lifecycle management, network and virtual environments, and Operational Excellence.
The position requires an extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, packaging equipment, Aseptic filling lines, automation, industrial networks, virtual environments, and field instrumentation technologies. Accountabilities & Responsibilities We are seeking an exceptional skilled individual who thrives in a fast-paced environment to support and implement our Automation solutions across our facility. As an Automation Engineer your job responsibilities include: Work schedule flexibility as required to support 24/7 operations, requiring occasional afterhours engineering coverage.
Supervisory Control and Data Acquisition systems (SCADA) preferably Rockwell’s Factory Talk View Systems Developing and trouble-shoot process control applications utilizing Programmable Logic Controllers (PLC) (Rockwell and Siemens PLCs) Develop and support Rockwell’s Data Historian, Asset Centre, Factory Talk Directory, etc. Troubleshoot day-to-day issues and provide guidance to junior engineers. Excellent understanding of control system philosophy, control system standards, instrumentation configuration, programming, and design in a c GMP environment.
Development of detailed specifications, engineering documents, SOPs, and engineering standards. Effectively interact and collaborate with cross-functional departments and clients to meet company expectations. Establish and maintain continuous improvement projects in support of company activities and growth. Ownership and administration of process control automation in a GMP regulated environment. Lead root cause analysis, incident investigations, and troubleshooting on process control issues related to electrical, instrumentation and control systems.
Support new product introductions or new technology introductions by performing engineering backssments, engineering studies, implementing automation system configuration changes, and supporting engineering runs. Support a safe working environment by complying with all pertinent environmental health and safety practices, rules, and regulations. Design and testing of newly installed and currently installed automation-based process and packaging equipment. Follow proper change control for any automation/process changes within the system. Lead and support of capital projects.
This role involves the application of advanced automation engineering principles in the design, specification, construction, startup, and validation of process equipment and systems. Support Network advancements and new technologies as it pertains to networking architectures. Education Master’s degree and 3 years of Engineering/Automation experience or Bachelor’s degree & 7 years of Engineering/Automation experience or Associate’s degree and 12 years of Engineering/Automation experience. Relevant Experiences Knowledge of systems such as Allen Bradley PLC platforms, (Control Logix and Compact Logix) Studio 5000 software Knowledge of Siemens PLCs and software (TIA Portal software) Knowledge of Factory Talk Directory, Factory Talk Asset Centre, Factory Talk Data Historian and WIN911, Knowledge and understanding of Data Integrity and how it applies to the medical Industry with specific focus on guidelines from the FDA.
Exceptional organizational and teamwork skills are required to be successful in this dynamic environment with changing priorities. Experience with regulatory inspections. Experience in sterile parenteral manufacturing. Experience with Aseptic Filling Systems (Fill lines and isolators) Knowledge/Experience of working in a GMP Environment Experience working with virtual environments.
(ESXI version 7.0, VMware Workstation, Virtual Network Configuration) Excellent project management and time management capabilities; with the ability to partner and influence across a matrixed environment. Excellent communication skills; verbal & written. Preferred Qualifications B. S. or M. S. in Electrical Engineering or Computer Science, Chemical Engineering, or related Life Science Engineering. Programming Switches, Firewalls, and designing networking architecture is preferred.
Strong control system automation background. Designing, installation, programming, validation of automated and computerized systems. Knowledge of industry standards for automated systems, virtual environments, IDMZs, and validation of computerized systems. Familiarity with 21 CFR Part 11, Data Integrity, and GAMP 5. 5+ years combined experience with the following product platforms: Rockwell PLCs (Control & Compact) Rockwell HMIs (IPC and Panel Views) Thin Manager/Thin Clients SQL Server design, implementation, and support. Independent. Self-motivated, organized, able to multi-task in a dynamic environment.
Ability to work in and embrace a team-based culture that relies on collaboration for effective decision-making. Working knowledge and experience with aseptic filling equipment, packaging equipment and single-use equipment. Experience with BMS, EMS systems, OPC, ODBC, Data Historians, WIN911, as well as Chillers, Boilers, HVAC and Wastewater systems. Experience in a GMP environment, change control, nonconformance, corrective and preventive actions, and validation practices.
