Manager, Manufacturing & Processing Engineering Facilities & Validation

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.

Why you'll love working at Axogen:

• Friendly, open, and fun team culture that values unique perspectives
• Company-wide dedication to profoundly impacting patients' lives
• Comprehensive, high-quality benefits package effective on date of hire
• Educational assistance available for all employees
• Matching 401(k) retirement plan
• Paid holidays, including floating holidays, to be used at your discretion
• Employee Stock Purchase Plan
• Referral incentive program

Axogen Mission and Business Purpose

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.

Job Summary of the Manager, Manufacturing & Processing Engineering

The Manager, Manufacturing & Processing Engineering will provide 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, which may include Manufacturing & Processing Engineering, Packaging & Labeling, Facilities & Validation, Cleaning & Sterilization, or other operational support functions, ensuring alignment with business objectives, regulatory requirements, and continuous improvement initiatives.

Requirements of the Manager, Manufacturing & Processing Engineering

• 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 and deliver highly technical information with clarity. This includes technical writing (e.g., protocols, reports, procedures, specifications, portions of regulatory submission documents) as well as preparing and 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

Responsibilities of the Manager, Manufacturing & Processing Engineering

The specific duties of the Manager, Manufacturing & Processing Engineering include but are not limited to:

• Manages an engineering team supporting one or more operational functions, including Processing, Packaging & Labeling, Facilities & Validation, and Cleaning & Sterilization, ensuring compliance with current Good Manufacturing Practices (cGMP) and all applicable federal, state, and local regulations.
• Executes actions while partnering with HR and senior leadership such as hiring, transfers, promotions, discharges, assignments, discipline, and compensation changes for assigned employees with the assistance of Human Resources.
• Plans, leads, and executes complex cross-functional projects impacting operations and other areas of the business.
• Lead implementation of new processes (e.g. process development associated with new products) into operations including writing SOPs, equipment & process validations, creating specifications, setting up new suppliers, training, and other collaboration with R&D, quality, regulatory, finance, supply chain, etc to successfully launch new processes. Includes leading cross-functional teams and project management to achieve successful implementation.
• Support Quality System compliance (examples 21 CFR part 820, 21 CFR Part 1271, 21 CFR Part 210/211, ISO 13485, ISO 9001, ISO 14971).
• Participates, analyzes, and makes recommendations for capital equipment investments, expense budget planning, and cost reduction planning efforts.
• Partners with Quality personnel for technical communications on quality issues.
• Utilizes root cause analysis methods and statistical tools to resolve processing issues. Develops and implements methods and procedures for inspecting, testing and evaluating products for acceptability.
• Ensures lean best practices are used to drive and support the Axogen Processing Center's continuous improvement projects to improve safety, quality, service levels, inventory, and cost.
• Leads the development and execution of equipment installation, operational qualifications, and process validations while analyzing product or equipment specifications and performance requirements to determine feasibility of new plant equipment or modifying existing equipment.
• Leads risk management evaluations.
• Develops and maintains support systems for production work processes.
• Ensures maintenance of the calibration program.

Location

913 Industrial Drive Place, Vandalia, OH 45377

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Benefits/Compensation

This position is eligible for an annual bonus.

Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.

Salary Range

$113,903-$142,378 USD

Company Statements

Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.

As AI is becoming a common tool throughout the application process, we want to be clear about its appropriate use at Axogen. Using AI to support resume writing, research or interview preparation is perfectly acceptable, provided the content is accurate and genuinely represents your qualifications and skills. For other key parts of your interview process, however, it is important that the ideas, communication, and work you share reflect your own voice, experiences, and thinking. We ask that you participate in our live interviews and complete any assessments without AI assistance unless instructions explicitly indicate otherwise or a specific exception is discussed and approved in advance. This approach ensures fairness, celebrates your individuality, and allows your authentic perspective to shine. Behaviors that do not align with these guidelines may result in disqualification from the hiring process or termination of employment if later discovered. We appreciate your understanding and look forward to learning about the unique contributions only you can bring to Axogen.

No agency solicitation. We kindly request that recruiting agencies, staffing firms, and third‑party vendors do not contact us regarding this posting. Unsolicited résumés will not be considered.