Manager, Manufacturing & Processing Engineering (Facilities & Validation)

About the role

Axogen’s mission is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. The Manager, Manufacturing & Processing Engineering provides focused project leadership and technical support to Operations with an emphasis on production support, decision-making, project management, equipment qualification, standard operating procedures, standard costing, capacity analysis, yield improvements, cost reduction, planning, validations and metrology. The Manager serves as the functional leader for a designated operations area (e.g., Manufacturing & Processing Engineering, Packaging & Labeling, Facilities & Validation, Cleaning & Sterilization) ensuring alignment with business objectives, regulatory requirements, and continuous improvement initiatives.

Responsibilities

• Manage an engineering team supporting one or more operational functions and ensure compliance with current Good Manufacturing Practices (cGMP) and all applicable federal, state, and local regulations.
• Partner with HR and senior leadership on hiring, transfers, promotions, discharges, assignments, discipline, and compensation changes for assigned employees.
• Plan, lead, and execute complex cross-functional projects impacting operations and other areas of the business.
• Lead implementation of new processes into operations, including writing SOPs, equipment & process validations, creating specifications, setting up new suppliers, training, and collaboration with R&D, quality, regulatory, finance, supply chain, etc. to successfully launch new processes.
• Support Quality System compliance (e.g., 21 CFR Part 820, 21 CFR Part 1271, 21 CFR Part 210/211, ISO 13485, ISO 9001, ISO 14971).
• Participate in capital equipment investment analysis, expense budget planning, and cost reduction planning efforts.
• Partner with Quality personnel for technical communications on quality issues.
• Use root cause analysis methods and statistical tools to resolve processing issues; develop and implement methods and procedures for inspecting, testing and evaluating products for acceptability.
• Ensure lean best practices are used to drive continuous improvement projects that improve safety, quality, service levels, inventory, and cost.
• Lead the development and execution of equipment installation, operational qualifications, and process validations; analyze product or equipment specifications and performance requirements to determine feasibility of new or modified plant equipment.
• Lead risk management evaluations and develop/maintain support systems for production work processes.
• Ensure maintenance of the calibration program.

Requirements

• Bachelor’s Degree in Engineering or related discipline and a minimum of 5 years of related experience OR a Master’s Degree in Engineering or related discipline and a minimum of 3 years of related experience.
• Preferred experience in biotech, biomedical, or pharmaceutical manufacturing.
• Experience in cGMP with alignment of AATB and FDA standards is preferred.
• Demonstrated presentation and communication skills at all levels; ability to deliver highly technical information with clarity, including technical writing (e.g., protocols, reports, procedures, specifications, portions of regulatory submission documents) and preparing/making presentations.
• Demonstrated hands-on technical skills.
• Preferred experience with Lean Six Sigma manufacturing.
• Experience with Microsoft Office Applications including Word, Excel, PowerPoint, and Outlook.

Benefits

• Health, Dental, Vision insurance.
• Matching 401(k) retirement plan.
• Paid Time Off and 9 Paid Holidays plus 3 Floating Holidays.
• Dependent Care and Medical Flexible Spending Accounts.
• Tuition Reimbursement.
• Paid Parental Leave and Paid Caregiver Leave.
• Basic and Supplemental Life Insurance.
• Employee Stock Purchase Plan.
• Short-term and Long-term Disability Insurance.

Pay

Salary range: $113,903—$142,378 USD.

Schedule

On-site at 913 Industrial Drive, Vandalia, OH 45377.