Senior Process Engineer-Media Fill
Jubilant HollisterStier
Senior Process Engineer-Media Fill
The position of Senior Scientist, Technical Services has functional responsibility for the media fill program at Jubilant HollisterStier in Spokane, WA. The Senior Scientist has responsibility for supervising and mentoring other personnel within the group and will communicate heavily with other functional teams. Essential responsibilities include:
Supervise and mentor personnel.
Evaluate incoming processes for robustness, efficiency and fit within existing media fill matrix at JHS-Spokane.
Perform media fill investigations, driving to root cause. Implement effective CAPAs designed to empower flawless execution.
Provide guidance and direction to all departments associated with media fills.
Ensure that all applicable U.S. and European regulatory requirements are being met within the procedures and practices related to media fills.
Review data summaries, assess the data for potential trends or conditions that may adversely impact the quality of the sterile products being manufactured, and ensure that corrective actions are implemented when required/warranted.
Provide necessary summaries and reviews for regulatory and customer inspectors/auditors; provide responses to written observations made by the inspector/auditors, and ensure that all corrective actions are completed as described and within the timeframe given in the response.
Review and approve assigned Standard Operating Procedures (SOPs), Protocols and Acceptance Reports from the perspective of scientific soundness and compliance with applicable regulatory requirements, and provide input/changes as needed.
Qualifications:
o Bachelors Degree in hard science or other technical field required. (Microbiology Degree preferred)
o 5 years related experience required.
o Pharmaceutical and FDA-regulated industry experience required.
o Prior experience in a solid professional or academic leadership position desired.
o Proficiency in Microsoft Word, Excel and PowerPoint required.
o Must have knowledge of cGMP's, regulatory requirements, relevant USP chapters, and scientific principles associated with clean room operations, media fills, sterilization, depyrogenation (dry heat and steam), endotoxin reduction, and microbiological monitoring and control.
o Physical Requirements: Prolonged sitting. Ability to work in aseptic areas required.Estimated Salary: $20 to $28 per hour based on qualifications.
Senior Process Engineer-Media Fill
The position of Senior Scientist, Technical Services has functional responsibility for the media fill program at Jubilant HollisterStier in Spokane, WA. The Senior Scientist has responsibility for supervising and mentoring other personnel within the group and will communicate heavily with other functional teams. Essential responsibilities include:
Supervise and mentor personnel.
Evaluate incoming processes for robustness, efficiency and fit within existing media fill matrix at JHS-Spokane.
Perform media fill investigations, driving to root cause. Implement effective CAPAs designed to empower flawless execution.
Provide guidance and direction to all departments associated with media fills.
Ensure that all applicable U.S. and European regulatory requirements are being met within the procedures and practices related to media fills.
Review data summaries, assess the data for potential trends or conditions that may adversely impact the quality of the sterile products being manufactured, and ensure that corrective actions are implemented when required/warranted.
Provide necessary summaries and reviews for regulatory and customer inspectors/auditors; provide responses to written observations made by the inspector/auditors, and ensure that all corrective actions are completed as described and within the timeframe given in the response.
Review and approve assigned Standard Operating Procedures (SOPs), Protocols and Acceptance Reports from the perspective of scientific soundness and compliance with applicable regulatory requirements, and provide input/changes as needed.
Qualifications:
o Bachelors Degree in hard science or other technical field required. (Microbiology Degree preferred)
o 5 years related experience required.
o Pharmaceutical and FDA-regulated industry experience required.
o Prior experience in a solid professional or academic leadership position desired.
o Proficiency in Microsoft Word, Excel and PowerPoint required.
o Must have knowledge of cGMP's, regulatory requirements, relevant USP chapters, and scientific principles associated with clean room operations, media fills, sterilization, depyrogenation (dry heat and steam), endotoxin reduction, and microbiological monitoring and control.
o Physical Requirements: Prolonged sitting. Ability to work in aseptic areas required.Estimated Salary: $20 to $28 per hour based on qualifications.
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