Job Description

Position: Associate Deviation Management Specialist 
Location: West Point, PA
Duration: 1 Year

Job Summary:
The Associate Deviation Management Specialist is primarily responsible for providing technical support to manufacturing operations, focusing on the resolution, reduction, and investigation of process deviations. This role involves developing and implementing corrective/preventative actions, leading manufacturing and laboratory investigations, and offering scientific support within the Client’s Manufacturing Division (MMD). The individual will collaborate with various departments involved in aseptic manufacturing, testing, planning, and release, utilizing scientific and engineering principles to investigate process deviations.

Responsibilities:

• Provide day-to-day technical support to manufacturing operations, ensuring the resolution and reduction of process deviations.
• Develop and implement corrective/preventative actions to address deviations and enhance operational efficiency.
• Lead investigations related to manufacturing and laboratory processes, employing sound scientific and engineering principles.
• Establish working relationships with counterparts in different areas supporting aseptic manufacturing, testing, planning, and release.
• Conduct troubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events.
• Design and execute laboratory/pilot scale experiments to analyze complex problems and facilitate process improvements.
• May be required to work off-shifts to support operational needs.

Qualifications:

• Bachelor's or Master's degree in an appropriate engineering or scientific field.
• Minimum of 4-8 years of post-Bachelor's degree experience in a cGMP environment within the pharmaceutical/biotech industry.
• Prior experience in writing investigations for atypical events in a manufacturing environment.
• Familiarity with Lean Six Sigma Methodologies and a proven track record in analytical problem-solving.
• Demonstrated ability to work independently and collaboratively within cross-functional teams.
• Excellent written and verbal communication skills.

Skills and Abilities:

• Proficiency in applying scientific and engineering principles to investigate and resolve process deviations.
• Strong analytical thinking and problem-solving capabilities to address complex issues.
• Ability to manage and prioritize multiple tasks in a fast-paced manufacturing environment.
• Excellent communication skills to collaborate effectively with diverse teams and present findings clearly.
• Adaptability and willingness to work off-shifts as necessary to support manufacturing operations.

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