Job Description

Title: Deviation Investigation Specialist

Location: West Point, PA

Duration: 12+ Months

Job Description:

• Primary responsibilities include day-to-day technical support to manufacturing operations, including resolution and reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing investigations.
• This individual will be responsible for providing scientific support for manufacturing areas within Clients Manufacturing Division.
• This Individual will also develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release and is required to utilize sound scientific and engineering principles to investigate process deviations Troubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events, development of corrective/preventative actions is required.
• Analysis of complex problems through critical analytical thinking Off-shift work may be required.

Qualifications:

• B.S./M.S. degree in appropriate engineering/scientific field Minimum of 3-5 years post-bachelor's degree experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industry.
• Previous experience in writing investigations for atypical events in a manufacturing environment Familiar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities.
• Demonstrated ability of meeting goals/timelines/organizational skills Excellent written and verbal communication skills.
• Demonstrated ability to work both independently and as a part of a cross-functional team Preferable skills-Environmental monitoring experience, Formulation and filling experience, Line manufacturing experience (project engineer, maintenance and facility engineer).

If you are not interested in looking at new opportunities at this time I fully understand. I would in that case be appreciative of any referrals you could provide from your network of friends and colleagues in the industry. We do offer a referral bonus that I’d be happy to extend to you if they turn out to be a great fit for my client.

Thank you for your time and for your consideration. I look forward to hearing from you.

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