Develop and implement manufacturing and engineering plans that align with company goals
and overall strategic direction.
Regularly monitor appropriate performance metrics, financial forecasts, and other metrics
to evaluate manufacturing and identify areas for improvement.
Refine and enhance processes by applying continuous improvement related to the
manufacturability of product and processes.
Independently evaluate existing equipment, methods and processes. Proactively identify technology and process gaps in manufacturing processes as well as opportunities for safety, cost, and
product quality improvement.
Motivate staff and provide technical direction and guidance, as well as hands-on project
management, recognizing the role as that of both manager and support resource /
Promote a healthy and safe work environment in compliance with all applicable laws and
Act as the primary information source for the team, maintaining compliance and
consistency, and taking corrective action when needed.
Ensure cGMP compliant processes and work instructions are accurate, current and
complete. Ensure manufacturing batch record review is effective while also
supporting the release schedule. Develop and review SOPs related to engineering
Lead S&OP process and capacity planning short and long-term.
Assure standards of manufacturability while validating customer and company
Lead and develop predictive, preventative maintenance and reactive maintenance
activities of equipment.
Assure the development of gauging methods meet regulatory requirements.
Manage the implementation of new equipment and /or modifications to existing to
improve plant efficiency and performance yields. Perform FAT/SAT on new
equipment as needed.
Bachelor’s Degree in Engineering (Required), plus a minimum of 5 years of experience as a manufacturing engineer and direct supervisory experience in a manufacturing environment.
Must be able to effectively coach and motivate employees.
Lean & Six Sigma experience a plus.
Experience in a pharma, life science or medical device environment.
Demonstrated success in turning around a manufacturing operations and making step-change in
cost or performance. Pragmatic and results driven.
Strong experience with regulations, cGMP and pharmaceuticals/medical device industry preferred. Knowledgeable with document change control process and CAPA process. Experience in deploying and managing ISO-compliant processes and organizations.
Strong problem solving acumen to determine failure modes and analysis, root causes using various methods (e.g., design of experiment, SPC, fault tree, etc.) that may result in changes in manufacturing, tooling and/or process methods.
Experience writing and executing process validation and documentation activities (IQ/OQ/PQ) is required.