Production Qualification Engineer
On-siteElizabeth, New Jersey, United States
Job Summary
Lead equipment, utility, and facility qualification projects at Actavis NJ sites, writing validation protocols and reports that challenge critical installation, operation, and performance parameters. Analyze data against acceptance criteria, generate deviation reports for failures, and compile engineering design documentation to support qualification. Prepare URS/FRS documents, execute engineering studies to establish operating parameters, and participate in factory acceptance testing and commissioning support. Monitor project timelines, communicate status, and facilitate new product launches by serving as a technical resource for Engineering, Operations, and R&D. Requires BS in Engineering, five years in pharmaceutical qualification, and cGMP/FDA experience.
Required Qualifications
- BS in Engineering (or other sciences)
- At minimum, five years of Qualification/Engineering experience in the Pharmaceutical industry specialized in solid oral dose
- In depth understanding of pharmaceutical equipment function and operation
- Experience in general quality assurance methods and practices in equipment / process / product validation, quality improvement, quality management systems, corrective and preventive action, root cause analysis
- Basic understanding of common GMP utilities such as HVAC and compressed air systems
- Experience with automated control systems such as programmable logic controllers
- cGMP Compliance and FDA PAI and Post Approval Inspection experience
- Diverse exposure to dosage forms including solid dosage forms
- Exposure to both Rx and OTC products
- Rx product experience
- Knowledge of pharmaceutical manufacturing operations to support the approval of protocols, reports, procedures and specifications
- Knowledge of for technical transfer of new and reformulated products including process scale-up and manufacture of pivotal batches
- Knowledge of regulatory requirements/guidelines
- Excellent technical writing, analytical and interpersonal skills
- Proficiency in Microsoft office tools (excel, word, power point, Access, Project)
- Regularly required to talk and hear
- Ability to stand, walk, bending and lifting
- Close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus
Desired Qualifications
- Exposure to both Rx and OTC products is desirable
- Exposure to both Rx and OTC products is desirable but Rx product experience is required
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