What are the responsibilities and job description for the Principal Aseptic Facility Engineer position at Medical Engineering Consultants (MEC)?
Position: Principal Aseptic Facility Engineer
Location: Minnesota
Type of Position: Contract to hire or direct hire
Hybrid: 3 days onsite and 2 days remote
Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.
MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).
MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.
About The Role
Client is searching for a Principal Aseptic Facilities Engineer to join the team. The Principal Facilities Engineer is responsible for ensuring the efficient and reliable operation of aseptic processing area at the manufacturing plant. This includes overseeing facilities infrastructure supporting APA ISO Clean Rooms and Life Safety systems. You will lead change management, system upgrades, and support continuous improvements to meet industry standards and regulatory requirements. The role requires leading internal and external audits, technical expertise on cGMP facility systems, strong project management skills, and the ability to collaborate with cross-functional teams to maintain high operational standards in a fast-paced manufacturing environment.
Your Responsibilities Will Include
MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of MEC and will not be obligated to pay a placement fee.
Check us out at www.medicalengineeringconsultants.com
AAP/EEO DFWP
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Location: Minnesota
Type of Position: Contract to hire or direct hire
Hybrid: 3 days onsite and 2 days remote
Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.
MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).
MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.
About The Role
Client is searching for a Principal Aseptic Facilities Engineer to join the team. The Principal Facilities Engineer is responsible for ensuring the efficient and reliable operation of aseptic processing area at the manufacturing plant. This includes overseeing facilities infrastructure supporting APA ISO Clean Rooms and Life Safety systems. You will lead change management, system upgrades, and support continuous improvements to meet industry standards and regulatory requirements. The role requires leading internal and external audits, technical expertise on cGMP facility systems, strong project management skills, and the ability to collaborate with cross-functional teams to maintain high operational standards in a fast-paced manufacturing environment.
Your Responsibilities Will Include
- Ensure the reliable operation of aseptic processing including ISO Clean Rooms, Incoming Power & Gas, Compressed Gases, Life Safety, Fire Protection, and Building Management system
- Lead facility system upgrades, end-of-life assessments, and improvement projects.
- Maintain ISO14644, ISO13408 certifications
- Lead Clean Room Design, Commissioning, and Qualifications.
- Lead cross-functional teams to resolve operational and quality-related non-conformance issues
- Participate in internal and external regulatory audits
- Assist with the annual budgeting process and ensure spending aligns with objectives
- Estimate design costs, coordinate with architects/ contractors, and ensure project schedules meet customer needs
- Bachelor’s degree in Mechanical/Electrical Engineering
- 7 years in facility engineering
- Experience in aseptic manufacturing, ideally within GMP facilities (pharma, med device, etc.)
- Strong knowledge of facilities systems, local building codes, government regulations, and good manufacturing practices
- Experience leading projects, adhering to schedules, and managing timelines
- Ability to manage competing priorities in a fast-paced environment
- Knowledge of ISO14644, ISO13408 including clean Room Design, commissioning, and qualifications
- Experience leading internal and external regulatory audits
- Proficiency in preparing design estimates, coordinating with contractors, and managing project execution
- Ability to work with engineering firms to develop design criteria and prepare layout and detail drawings
MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of MEC and will not be obligated to pay a placement fee.
Check us out at www.medicalengineeringconsultants.com
AAP/EEO DFWP
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
