Job Description

Job Title: Deviation Investigator

Duration: 12 Months

Location: West Point, PA

Industry: Pharmaceutical / Biologics Manufacturing

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.

• 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.

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.

• 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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