Manager, Manufacturing & Processing Engineering (Facilities & Validation)

Axogen•Vandalia, OH

1d•Onsite

About The Position

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

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.
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
Experience with Microsoft Office Applications including Word, Excel, PowerPoint, and Outlook

Nice To Haves

Preferred experience in biotech, biomedical, or pharmaceutical manufacturing.
Experience in cGMP with alignment of AATB and FDA standards is preferred.
Preferred experience with Lean Six Sigma manufacturing

Responsibilities

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.