Job Description
Job Title: Deviation Investigator
Duration: 12 Months
Location: West Point, PA
Industry: Pharmaceutical / Biologics Manufacturing
Position Summary: A leading pharmaceutical organization is seeking a
Deviation Investigator to support its quality and compliance operations within a high-volume sterile manufacturing facility. This role focuses on conducting thorough investigations, driving root cause analysis, and contributing to continuous improvement initiatives in a regulated environment. The ideal candidate will be a skilled technical writer with strong communication and problem-solving abilities, and a comfort level in navigating complex production environments.
Key Responsibilities: - Lead and support investigations into deviations, including impact assessments, root cause determination, and implementation of effective corrective and preventive actions (CAPAs).
- Author, review, and maintain GMP-compliant documentation such as SOPs, batch records, protocols, change controls, and validation reports.
- Collaborate cross-functionally with Manufacturing, Quality, Engineering, and external stakeholders to collect evidence, conduct interviews, and ensure timely closure of investigations.
- Support production floor activities by addressing technical and operational challenges related to equipment, process, or quality.
- Manage and track project timelines to ensure compliance and operational milestones are achieved.
- Participate in and/or lead initiatives to improve compliance, operational efficiency, and deviation reduction.
- Apply a holistic approach when troubleshooting issues, considering aspects such as safety, automation, equipment design, and human factors.
- Contribute to site-level improvements and continuous improvement efforts in a biologics or sterile manufacturing environment.
Qualifications: Education: - B.S. or B.A. in Engineering, Life Sciences, or a related technical discipline.
Experience: - 2 to 4 years in a regulated pharmaceutical, vaccine, or biologics manufacturing environment (co-op or internship experience may be considered).
- Demonstrated experience with deviation management, root cause analysis, and CAPA development.
- Familiarity with GMP guidelines and documentation practices.
Skills & Competencies: - Technical Writing: Exceptional ability to author clear, accurate, and compliant documentation.
- Communication: Strong verbal and written communication skills; confident conducting interviews and presenting findings.
- Analytical Thinking: Ability to analyze complex problems and propose effective solutions.
- Project Management: Capable of managing investigations and documentation tasks to strict deadlines.
- Teamwork: Collaborates effectively across multiple functions and departments.
- Preferred: Experience in sterile or bulk manufacturing, change control processes, and deviation systems.
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Job Tags
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