GMP Engineering Manager

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Join to apply for the GMP Engineering Manager role at Exela Pharma Sciences LLC

Position Summary

The GMP Engineering Manager advises the Quality Assurance department in ensuring cGMP compliance of all relevant FDA regulations and internal procedures / specifications relating to oversight of engineering functions at Exela. Specifically, he / she must ensure all equipment installed, qualified, or validated at the site undergoes proper change controls. In this role, they review and approve all engineering change controls. Ability to prioritize workload to meet timelines in a fast-paced environment are critical.

Position Summary

The GMP Engineering Manager advises the Quality Assurance department in ensuring cGMP compliance of all relevant FDA regulations and internal procedures / specifications relating to oversight of engineering functions at Exela. Specifically, he / she must ensure all equipment installed, qualified, or validated at the site undergoes proper change controls. In this role, they review and approve all engineering change controls. Ability to prioritize workload to meet timelines in a fast-paced environment are critical.

Job Responsibilities

• Oversee engineering change management program
• Provide quality support and oversight for commissioning, qualification and validation of new and existing processes
• Participate in the definition of user requirements and ensure they conform with regulatory guidance
• Assure CPPs are defined and understood by engineering and incorporated into design and control functions
• Assure risk management decisions are done in a disciplined manner to document decisions and rationale
• Assure any GMP data captured and managed by engineering is stored and maintained in a compliant CSV manner
• Represent the company during contact with the FDA and other regulatory agency audits

Required Skills

Education And Experience Requirements

EOE Disability / Veterans

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Engineering and Information Technology

Industries

Pharmaceutical Manufacturing

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