Deviation Management Specialist

Deviation Management Specialist

We are seeking a detail-oriented Deviation Management Specialist to provide scientific and technical support within a cGMP-regulated manufacturing environment. This role partners closely with cross-functional teams to investigate process deviations, resolve atypical events, and implement effective corrective and preventative actions (CAPAs). The ideal candidate brings strong analytical thinking, technical writing expertise, and a collaborative approach to supporting pharmaceutical or biotech manufacturing operations.

Responsibilities:

• Provide day-to-day technical support to manufacturing operations, focusing on the resolution and reduction of process deviations.
• Lead manufacturing and laboratory investigations, including root cause analysis for atypical events and test failures.
• Develop and implement corrective and preventative actions (CAPAs) to ensure compliance and continuous improvement.
• Apply sound scientific and engineering principles to investigate process deviations and manufacturing issues.
• Design and execute laboratory and/or pilot-scale experiments to analyze complex technical problems.
• Collaborate cross-functionally with teams supporting aseptic manufacturing, testing, planning, and product release.
• Develop strong working relationships across Manufacturing, Technical Services, Quality, and related departments.
• Support continuous improvement initiatives utilizing Lean Six Sigma methodologies.
• Participate in off-shift support activities as required.

Education:

Bachelor’s (B.S.) or Master’s (M.S.) degree in Engineering, Science, or a related technical field required.

Experience:

• 0–3 years of post-bachelor’s experience in a cGMP-regulated environment within the pharmaceutical or biotechnology industry.
• Experience in Production, Development, Process Engineering, Technical Services, or a related function preferred.
• Prior experience writing investigations for atypical events in a manufacturing environment required.
• Familiarity with Lean Six Sigma methodologies and demonstrated analytical/problem-solving capabilities.
• Proven ability to work both independently and collaboratively within cross-functional teams.

Additional Information:

• Excellent written and verbal communication skills required.
• Strong organizational skills and attention to detail are essential.
• Role may require off-shift support based on manufacturing needs.