Sr. Manager, Validations and Engineering

At PBI-Gordon Companies, and our subsidiaries PBI-Gordon Corporation, Pegasus Laboratories, and PetAg, Inc, our priority is people, pets, and the places they go. As employee owners, we support each other in building our careers as well as our companies. Our foundation is rooted in integrity, innovation, partnership, and pride. Come grow with us!

SUMMARY:

The Sr. Manager, Validations and Engineering provides technical leadership in product and process development, validation, and engineering. The role will manage the product validation life cycle post FDA approval through continued process verification and manages the engineering and validation team as service providers for equipment qualifications, cleaning validations, process validations, and tech transfer projects.

RESPONSIBILITIES:

• Manages the Site Validation Master Plan and Product Validation Master Plans for assigned projects and/or products in cGMP facility.

• Manages technical transfer projects, from formulations scale-up to approval and launch.

• Oversees implementation of capital equipment projects supporting new product launches including budgets, design qualification, user requirement specifications, and qualification. Develop project plans, timelines, and reporting.

• Oversees design and execution of sampling and sample preparation for cleaning validation, process, and packaging validation protocols.

• Manages and monitors ongoing product validation activities including cleaning and manufacturing processes, utilizing a risk-based approach to establish and maintain the product-specific validation program.

• Provides resources, support, and oversight to qualify new equipment lines and technical transfer projects and works cross-functionality to manage timelines.

• Provides technical support and training to the production team, new employees and advises EH&S on equipment, cleaning procedures, and manufacturing processes.

• Coordinates with CMC team to provide supporting documentation for FDA submissions including process validation protocols, process development reports, FMEA reports, process flow diagrams, and SUPAC supporting documents.

• All other tasks as requested or assigned.

QUALIFICATIONS AND REQUIREMENTS:

• Bachelor's degree in Engineering, Chemistry, Pharmaceutical Science, or related disciple. Advance degree preferred.

• 7+ years' experience with cGMP/FDA regulated pharmaceutical process development and validations experience including process validations, cleaning validations, scale-up, equipment qualifications, statistical process performance, and knowledgeable about SUPAC, USP, ICH, AND VICH guidelines.

• 5+ years' experience in People Leadership and Project Management required.

• cGMP FDA regulated facility experience required with a background in budgeting, documentation (i.e., cGMP protocols, reports, system investigations, lab notebooks), and technical writing.

• Proficient with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint)

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