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Job Title: Commissioning & Qualification Professional/Validation Engineer
Location: Fogelsville, PA
Need these skills
Bachelor’s degree in engineering, Life Sciences, or a related technical field.
5+ years of experience in commissioning, qualification, and/or validation within the pharmaceutical or biotech industry.
Hands-on experience in aseptic manufacturing environments.
Skilled with GxP, FDA regulations, and validation.
Experience with black utilities (e.g., WFI, clean steam) and/or laboratory analytical equipment.
Familiar with electronic validation systems, Kneat is highly preferred.
Experience in review protocols including IQ, OQ, and PQ documentation in alignment with regulatory standards.
Please provide any and all CVs with ideally 4+ years experience who fit within the provided rate.
Required
- Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
- 5+ years of experience in commissioning, qualification, and/or validation within the pharmaceutical or biotech industry.
- Hands-on experience in aseptic manufacturing environments.
- Strong knowledge of GxP, FDA regulations, and validation lifecycle requirements.
- Experience with black utilities (e.g., WFI, clean steam) and/or laboratory analytical equipment qualification.
- Familiarity with electronic validation systems such as Kneat is highly preferred.
- Prior experience supporting large-scale pharmaceutical manufacturing projects is a plus.
- Strong technical writing, communication, and problem-solving skills.
- Ability to work both independently and in a collaborative team environment.
Responsibilities:
- Commissioning & Qualification (C&Q) professionals to support aseptic manufacturing operations within a regulated life sciences environment.
- Role will focus on executing commissioning, qualification, and validation activities for critical systems, utilities, and laboratory equipment to ensure compliance with GxP and regulatory requirements.
- Execute commissioning and qualification (C&Q) activities for aseptic manufacturing equipment, utilities, and systems.
- Develop and/or review protocols including IQ, OQ, and PQ documentation in alignment with regulatory standards.
- Support startup and validation of black utilities (e.g., WFI, clean steam, process gases).
- Perform qualification activities for laboratory analytical instruments and equipment.
- Collaborate cross-functionally with engineering, quality, validation, and manufacturing teams.
- Ensure all activities comply with GxP, FDA, and applicable industry guidelines.
- Utilize electronic validation systems (e.g., Kneat) for protocol execution and lifecycle documentation.
- Troubleshoot issues during commissioning and qualification phases and support resolution efforts.
- Maintain thorough and accurate documentation to support audits and inspections.
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