GMP Engineering Manager - Exela Pharma Sciences : Job Details

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:

• 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