GMP Engineering Manager

Exela Pharma Sciences LLC • Lenoir, NC, US

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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

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

Must possess strong knowledge of sterile drug product manufacturing. Alternatively, strong background in medical device manufacturing with clean room experience, or strong manufacturing experience in the food and beverage industry with clean room and clean utilities experience

Must have at least 3 years experience in working with packaging equipment

Must be detail-oriented with exceptional planning and organizational skills

Must be an effective communicator both up and down the organizational structure

Mentoring and training of new employees is an essential skill for this position

Education And Experience Requirements

Bachelor's degree required in a scientific discipline or related field. In rare instances, a combination of education and relevant work experience may be acceptable in lieu of a Batchelor's degree.

Strong competency in C&Q / CSV / GAMP and Validation practices.

Minimum 4-5 years' experience working in GMP manufacturing and / or engineering environment required.

EOE Disability / Veterans

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Engineering and Information Technology

Industries

Pharmaceutical Manufacturing

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Engineering Manager • Lenoir, NC, US