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.
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.
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First Name, Last Name, Email, Phone, Resume/CV, Cover Letter, Location
- Are you over the age of 18 years old? choose one
- Are you able to perform the essential functions of this position, with or without reasonable accommodation? choose one
- Are you able to provide proof of your right to work in the US if hired? choose one
- Do you now, or in the future, will you require sponsorship by Axogen to work in the US? choose one
- Do you have any relatives or household members working at Axogen or an Axogen partner currently? If yes, who? written answer
- Have you previously worked for Axogen? choose one
- What are your compensation expectations (please list salary or hourly rate and bonus/commission separately)? written answer
- Do you have an active non-compete or similar agreement that might prevent you from being permitted to work with Axogen? If yes, please email a copy to: talentacquisitioninterviews@axogeninc.com. choose one
- If you accept an offer of employment from us, we will need your legal name as it appears on your social security card or other legal documents. Please provide your legal name below, including any suffixes (ex. Jr., Sr., III) written answer
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- What is the highest level of education you have completed and area of focus?
- How many years of experience do you have in engineering leadership role from a medical device, pharmaceutical or biotech company?
- How many years of experience do you have directly managing a team within an FDA regulated environment?
- Are you local to Vandalia, OH or relocating?
- Do you have facilities & validation experience from an FDA regulated industry? choose one
- APPLICATION ACKNOWLEDGMENT I acknowledge that I have read this Application for Employment. I acknowledge that I understood each and every question that was asked of me in the Application for Employment. I acknowledge that I was given the opportunity by Axogen to ask questions regarding the Application for Employment and the hiring process. I acknowledge that if Axogen employs me, I will be free to leave Axogen at any time for any reason and that Axogen is free to separate my employment at any time and for any reason without prior notice. I understand that this is called “employment at will,” and no one other than an officer of Axogen has the authority to alter this arrangement, to enter into an agreement for employment for a specified period of time, and/or to make any agreement contrary to the at-will nature of my employment. Furthermore, I understand that any such agreement that is contrary to the at-will nature of my employment must be in writing signed by an officer of Axogen. I acknowledge and understand that by submitting this application, Axogen may use some of the information stated in this application and my resume if provided to: conduct necessary background or credit checks, contact references and prior employers, verify licenses, or obtain any other relevant information deemed necessary. Further, if I am offered a position by Axogen, the job offer is contingent on the satisfactory completion of: a background check, a drug test, any job-related medical evaluation, any job-related quality training, proof of my legal identification, and authorization to work in the United States, and verification of any of the information that I provided. I acknowledge and affirm that the answers I have provided in this application and resume (if provided) for employment are true and accurate. I further acknowledge that I have not withheld any information that was requested of me in this application for employment. I understand and acknowledge that any misrepresentations, false statements, and/or omissions made by me in completing this application for employment may result in me not being considered for employment by Axogen and/or may lead to disciplinary action, up to and including the separation of my employment if discovered by Axogen after I have been hired. Therefore, I agree that if I am hired by Axogen, and I unknowingly wrote or later learn that something false or inaccurate is on this application, I am required to correct any and all inaccurate statements. choose one