but not submit an application for this open position. ) Thank you. Description Overview The Sr Computer System Validation Engineer provides Quality oversight of Global IT projects. They will partner with project stakeholders to effectively and efficiently implement and validate new systems, system upgrades, or system modifications.
Please note: This position can work 100% remote or near a Perrigo location with a hybrid schedule if desired. Scope of the Role Works with IT and user groups to evaluate change control requests by backssing regulatory risk and determining corresponding validation requirements. Author, review, or approve lifecycle documents (URS, Validation Plan, Specifications,
Risk backssment, Qualifications IQ/OQ/PQ, data integrity evaluations, trace matrix, SOPs, and Validation Summary Reports). Reviews global policies, SOPs, and work instructions supporting the quality management system and computerized/IT applications and infrastructure Maintains the site Validation Master Plan and systems catalog.
Perform CSV periodic review for IT systems. Experience Required High level of analytical skills with proven problem-solving ability, and good interpersonal skills. Demonstrated ability to organize multiple tasks and to change priorities to meet project deadlines. Ability to work with cross-functional group at all levels of organization. Working knowledge of computer
validation requirements in government regulations including, 21 CFR Part 11, Annex 11, data integrity, and GAMP.
Ability to write technical documents relating to applications and computer systems of medium to high complexity. Demonstrated thorough understanding of validation processes and interpretation and application of FDA, EU, and c GMP requirements. Bachelor’s degree in Computer Science, Engineering, Programming, or a related field. A minimum of 7 years of medical industry experience preferred. External applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.
) Thank you. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. Our full Equal Employment Opportunity and Affirmative Action Policy Statement is available on our main career site in English and Spanish and will be provided in other accessible forms for persons with disabilities. #DIV
around the world. Grace employs approximately 4,300 people in over 30 countries. Job Description Grace is a seeking a Process Safety Engineer who will be responsible for the Process Safety Management (PSM) systems at our South Haven, MI site. This person will report to the Plant Manager.
The South Haven Site produces a portfolio of products for the specialty medical industries, specifically Active medical Ingredients. Consisting of a c GMP kilo lab, pilot plant and custom manufacturing at the commercial volumes, the site is fully equipped to develop and manufacture custom drug intermediates and API’s. South Haven is nestled on the coast of Lake Michigan with beautiful beaches and fun
year-round. Will pay for all relocation expenses. Responsibilities Execute the Process Safety programs in a process facility subject to OSHA 29 CFR 1910.119 Management of Highly Hazardous Chemicals and as implemented by MIOSHA Part 91, and EPA Risk Management Program (RMP) 40 CFR Part 68 Chemical Accident Prevention Provisions Facilitate Process Hazard Analyses (PHAs), incorporating industry best-practice methodologies, and Layer of Protection Analysis (LOPA) studies Ensure PHAs are conducted efficiently and effectively following corporate policy Maintain documentation of PHAs and Process Safety Information (PSI) Maintain and update the site’s RMP plan as required by 40 CFR Part 68 Review and
update Process Safety SOPs within the site’s document management system Conduct Root Cause Analyses (RCAs) as required Recommend safeguards to mitigate risks identified in PHAs Recommend engineering controls as solutions to RCAs or other projected as requested Facilitate periodic Corporate PSM audit and manage audit team Manage the Corrective Action/Preventative Action (CAPA) system Monitor the Incident Reporting and Management of Change (MOC) systems for regulatory compliance and adherence to corporate expectations Develop training content and protocols for the EHSS team Administer select training curriculum to new employees Address hazards, deviations, and injuries in a timely manner Available for on-call and after hours work as needed Other duties/assignments, as requested Required Qualifications BS Degree in Chemical or Mechanical Engineering Minimum of 7 years of chemical industry experience, with supervisory and Process Safety leadership experience Subject matter expertise in application of HAZOP/What-If, PHA, Root Cause, Layer of Protection Analysis (LOPA), or demonstrated ability to learn these topics High level of personal motivation, with a drive for ownership and accountability in performance of job responsibilities Leadership of teams in a manner that encourages collaboration, focus, and energy Strong demonstrable knowledge of applicable regulations (OSHA, NFPA, etc) Proficient in using MS Office products High level of personal motivation, with a drive for ownership and accountability in performance of job responsibilities Ability to provide consultation and advice to a diverse audience effectively Ability to handle multiple compliance tasks and decisions with minimal supervision Preferred Qualifications Ability to deliver relevant information in an enthusiastic, clear, concise and accurate way to promote individual and team commitment Possess superior technical writing and interpersonal skills In-depth knowledge of OSHA 29 CFR 1910.119 and EPA 40 CFR Part 68 Benefits Benefits Link: U.
S. Employee Benefits Summary () Medical, Dental, Vision Insurance Life Insurance and Disability Grace Wellness Program Flexible Workplace Retirement Plans 401(k) Company Match Paid Vacation and Holidays Parental Leave Tuition Reimbursement Company Donation Match Program Grace is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Grace via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Grace.
No fee will be paid in the event the candidate is hired by Grace as a result of the referral or through other means.
to develop and manufacture custom drug intermediates and API’s. South Haven is nestled on the coast of Lake Michigan with beautiful beaches and fun year-round. The Reliability/Maintenance Engineer is responsible for providing the technical program leadership and implementation activities described below to maximize the maintenance related uptime and operating efficiencies of equipment and facility assets.
These activities help minimize costs and contribute to the profitability and performance of the business. Under the direction of the Maintenance Manager the Reliability/Maintenance Engineer monitors the status of their reliability maintenance program evolution relative to corporate program
strategies. This position provides measurements of program progress and effectiveness such as preventive maintenance, condition-based monitoring work, equipment uptime, overall equipment effectiveness and mean time between failures.
They facilitate the identification and communication of the root causes of losses in the operation of production, facility, and utility processes. The Reliability/Maintenance Engineer is responsible for ranking the criticality of the assets under their care, typically using Reliability Centered Maintenance approaches, and for defining the proactive maintenance approaches that are cost beneficial to the business. The incumbent specifies parts, inventory quantities
and the special storage requirements for critical spare parts.
They represent reliability maintenance to other organizations and functions including Engineering Design, Production Operations, Procurement, Storeroom operations, new project commissioning, etc. They provide reliability maintenance input to Engineering Design to create designs which minimize life cycle costs. They develop procedures and specifications for the reliability maintenance aspects of existing and new equipment, and they help identify the work content of planned shutdowns. Responsibilities • Promotes the use of Reliability Engineering concepts and tools to the Engineering and Production departments.
• Communicates changes and updates resulting from Strategy and Continuous Improvement efforts, and Project implementation activities. • Assists operations and maintenance manager with equipment improvements that improve asset reliability. • Generates change control documentation as required by reliability initiatives (i. e. Bad Actor reporting, Capital Projects, etc. ) • Writes equipment MOCs required for new equipment and or modified equipment. • Establishes guidelines and specifications (i. e. Task, Frequency, Materials, Skill, Calibration parameters, etc. ) for properly implementing equipment Preventive Maintenance and equipment health activities.
• Develops, changes, and initiates maintenance activities (PM, CBM, lubrication, calibration, training, and spare parts) as based on analysis results (FMEA / RCM) to improve performance and equipment availability • Identifies chronic equipment (classification based) deficiencies through “Bad Actor” and cost analysis, Failure Mode, and Effect analysis (FMEA), and equipment history reviews. • Performs reliability analysis (FMEA / RCM) to identify root causes of chronic ongoing equipment issues. • Updates the Maintenance Strategy and Reliability Ranking Index for equipment as based upon reliability analysis (RCM or FMEA) and bad actor reporting.
• Develops equipment reliability plans that reduce the number of failures and minimizes the effects of failures that do occur. • Responsible for updating the criticality ranking of the assets under their care, typically using results from Bad Actor reporting and analysis, PM / Calibration Optimization and Rationalization actives, and FMEA / RCM approaches. • Provides Life Cycle Cost Modeling and Statistical Analysis to Project Engineering for equipment design and selection.
• Provides “Design for Reliability” input to capital projects with respect to equipment specifications that create project approaches which minimize life cycle costs. • Provides input and oversight to equipment standards. • Develops procedures and specifications for the reliability maintenance aspects for existing and new equipment. Required Qualifications • Bachelors or master’s level degree (Mechanical Engineering preferred) • Knowledge of respective techniques, practices, precedents, theory, and principles. • Equipment reliability principles and Pd M disciplines knowledge preferred • Advanced computers use skills, knowledge of CMMS, Reliability, and NDT software tools preferred • Previous reliability / maintenance engineering experience preferred.
Project management experience and/or equipment reliability principles knowledge preferred. • Good communication skills and the ability to interact with all departments. Preferred Qualifications • Bachelors or master’s level degree (Mechanical Engineering preferred) • Knowledge of respective techniques, practices, precedents, theory, and principles. • Equipment reliability principles and Pd M disciplines knowledge preferred • Advanced computers use skills, knowledge of CMMS, Reliability, and NDT software tools preferred • Previous reliability / maintenance engineering experience preferred.
Project management experience and/or equipment reliability principles knowledge preferred. • Good communication skills and the ability to interact with all departments. • Previous reliability / maintenance engineering experience or internships preferred. • Project management experience and/or equipment reliability principles knowledge preferred. #WRGRACE #INDEED Benefits U. S. Employee Benefits Summary () • Medical, Dental, Vision Insurance • Life Insurance and Disability • Grace Wellness Program • Flexible Workplace • Retirement Plans • 401(k) Company Match – Dollar to dollar up to the first 6% • Paid Vacation and Holidays • Parental Leave (salaried only) • Tuition Reimbursement • Company Donation Match Program • Site specific contribution to local Wellness Center
