Manufacturing & Engineering Manager
Key manager role with a start-up medical device manufacturer
Opportunity to lead a growing team
About Our Client
Our client is a start up medical device company that focuses on manufacturing products for the Animal Health and Surgical markets.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
- Oversee all process engineering activities including process improvements, process scale-ups, process technology transfers and process validations.
- Oversee all facilities engineering, including maintenance and repair of all aseptic manufacturing facility infrastructure, HVAC/major mechanical equipment, electrical, plumbing, roofing, utilities, and other infrastructure systems.
- Act as a technical thought leader in process engineering, facilities engineering and equipment reliability, including providing technical expertise and scientific leadership in troubleshooting, root cause analysis and data trending toward continued manufacturing process and facility improvements.
- Lead the expansion of company's manufacturing locations, including site selection, securing bids, managing contracts, oversight of all execution activities.
- Ensure all engineering projects, initiatives, and processes are in conformance with the organization's established policies and objectives as well as in adherence to OSHA, NFPA and other applicable safety codes.
- Contributes to strategic planning by evaluating and projecting future process and facility needs and proposing options to achieve them.
- Ensure compliance with all applicable specifications, standard operating procedures (SOPs), and FDA regulations.
The Successful Applicant
- Bachelor's degree in engineering or equivalent technical field required.
- MS degree in Engineering or closely related technical field or MBA preferred.
- 10 years of aseptic manufacturing experience is required.
- A minimum of 5+ years of direct management experience required, with the ability to manage engineers, scientists and technicians and influence, motivate and drive technical rigor.
- Expertise in technical / process design, development, and process / technology transfer with a thorough understanding of regulatory requirements.
- Experience with semisolid aseptic formulation and syringe filling lines is strongly preferred.
- Strong knowledge of medical device regulations (e.g., 21 CFR Part 820), cGMP, and related standards (e.g., ISO 13485) is required.
- Experience managing a biotech facility, including a combination of manufacturing, research, and office space. Experience scaling operations and building new space is preferred.
- Demonstrated ability to execute priorities in a fast-paced environment, working under pressure with tight timelines with the ability to maintain a sense of priorities focus and urgency.
- Excellent written and verbal communication skills, good interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators) are required.
What's on Offer
- Competitive base salary and bonus potential
- Paid vacation and holidays
- Medical, Dental, and Vision Insurance
- Firm Paid Life and Short-Term Disability Coverage
- 401(k) Retirement Savings Plan