Polaris Pharmaceuticals Inc.
Validation Engineer II, Cleaning Validation
Polaris Pharmaceuticals Inc., Vacaville, California, United States, 95688
Department
Validation FLSA Status
Exempt Salary Range
$120K/yr ~ $140K/yr CORE VALUES
2024 ROLE SUMMARY
The Validation Engineer II (cleaning validation), under minimal supervision, is responsible for performing commissioning, qualification, and validation of biopharmaceutical equipment and facilities following cGMP guidelines. The prospective candidate must have experience with cleaning validation and equipment/facilities qualification and validation. The candidate is required to create and maintain schedules for validation activities, and the ability to communicate and coordinate with other departments is required. As part of the Polaris Validation group, candidate may assist with capital projects and technology transfer, having an understanding of Upstream (Fermentation), Downstream (Recovery/Purification), and AFS (Aseptic Fill Suite/Drug Product) manufacturing processes is encouraged. ROLE RESPONSIBILITIES
Follow Polaris’ validation procedures to develop qualification strategies for a wide range of systems and processes, but primary focus is on execution/ownership of site cleaning validation program. Review, and/or author validation protocols. Plan and execute cleaning validation activities, including spray coverage testing and lab scale studies. Create and maintain validation schedules. Author, review, and execute FAT, SAT, IQ, OQ, PQ and other commissioning/qualification protocols as necessary. Review and draft risk assessment reports. Perform gap assessments related to cleaning validation. Perform periodic review and re-qualification programs, and execute re-qualification activities as necessary. Don cleanroom attire such as coveralls, frocks, and boot covers and enter cleanroom areas as required. Assist with deviations, change controls, and process improvement activities. Ensure cleaning validation approach meets FDA, EU, and other regulatory requirements. SKILLS
Knowledge of regulatory requirements for cleaning validation of processes and equipment. Experience authoring, reviewing, and executing Qualification/Validation protocols. Good record keeping, organizational, written, and verbal communication skills are essential. Ability to adapt to rapidly changing schedules and requirements. Ability to work and communicate with cross-departmental teams. Strong documentation skills are required. Experience working in a heavily regulated cGMP environment. Experience working in cleanrooms, including gowning, material transfer, and appropriate cleanroom behavior. QUALIFICATIONS
B.S./B.A. in Engineering/Science Related Field. 5-9 years of relevant cGMP experience, including validation experience, is desired. MS Degree in Engineering/Science Related Field. 3-6 years of relevant cGMP experience, including validation experience, is desired. PhD in Engineering/Science Related Field. 1-3 years of relevant cGMP experience, including validation experience, is desired. Seniority level
Mid-Senior level Employment type
Full-time Job function
Manufacturing, Quality Assurance, and Engineering Industries
Biotechnology Research and Pharmaceutical Manufacturing Benefits
Medical insurance Vision insurance 401(k) Referrals increase your chances of interviewing at Polaris Pharmaceuticals Inc. by 2x Get notified when a new job is posted.
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Validation FLSA Status
Exempt Salary Range
$120K/yr ~ $140K/yr CORE VALUES
2024 ROLE SUMMARY
The Validation Engineer II (cleaning validation), under minimal supervision, is responsible for performing commissioning, qualification, and validation of biopharmaceutical equipment and facilities following cGMP guidelines. The prospective candidate must have experience with cleaning validation and equipment/facilities qualification and validation. The candidate is required to create and maintain schedules for validation activities, and the ability to communicate and coordinate with other departments is required. As part of the Polaris Validation group, candidate may assist with capital projects and technology transfer, having an understanding of Upstream (Fermentation), Downstream (Recovery/Purification), and AFS (Aseptic Fill Suite/Drug Product) manufacturing processes is encouraged. ROLE RESPONSIBILITIES
Follow Polaris’ validation procedures to develop qualification strategies for a wide range of systems and processes, but primary focus is on execution/ownership of site cleaning validation program. Review, and/or author validation protocols. Plan and execute cleaning validation activities, including spray coverage testing and lab scale studies. Create and maintain validation schedules. Author, review, and execute FAT, SAT, IQ, OQ, PQ and other commissioning/qualification protocols as necessary. Review and draft risk assessment reports. Perform gap assessments related to cleaning validation. Perform periodic review and re-qualification programs, and execute re-qualification activities as necessary. Don cleanroom attire such as coveralls, frocks, and boot covers and enter cleanroom areas as required. Assist with deviations, change controls, and process improvement activities. Ensure cleaning validation approach meets FDA, EU, and other regulatory requirements. SKILLS
Knowledge of regulatory requirements for cleaning validation of processes and equipment. Experience authoring, reviewing, and executing Qualification/Validation protocols. Good record keeping, organizational, written, and verbal communication skills are essential. Ability to adapt to rapidly changing schedules and requirements. Ability to work and communicate with cross-departmental teams. Strong documentation skills are required. Experience working in a heavily regulated cGMP environment. Experience working in cleanrooms, including gowning, material transfer, and appropriate cleanroom behavior. QUALIFICATIONS
B.S./B.A. in Engineering/Science Related Field. 5-9 years of relevant cGMP experience, including validation experience, is desired. MS Degree in Engineering/Science Related Field. 3-6 years of relevant cGMP experience, including validation experience, is desired. PhD in Engineering/Science Related Field. 1-3 years of relevant cGMP experience, including validation experience, is desired. Seniority level
Mid-Senior level Employment type
Full-time Job function
Manufacturing, Quality Assurance, and Engineering Industries
Biotechnology Research and Pharmaceutical Manufacturing Benefits
Medical insurance Vision insurance 401(k) Referrals increase your chances of interviewing at Polaris Pharmaceuticals Inc. by 2x Get notified when a new job is posted.
#J-18808-Ljbffr