Validation Engineer
Job in
Fogelsville, Lehigh County, Pennsylvania, 18051, USA
Listed on 2026-06-02
Listing for:
3B Staffing
Full Time
position Listed on 2026-06-02
Job specializations:
-
Engineering
Validation Engineer, Biomedical Engineer, Pharma Engineer, Quality Engineering
Job Description & How to Apply Below
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.
- 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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