Boston Scientific Principal Facilities Engineer - Aseptic Manufacturing 

United States, Minnesota 

597425833

About the Role:

We are searching for a Principal Facilities Engineer to join our team in Maple Grove, MN. The Principal Facilities Engineer is responsible for ensuring the efficient and reliable operation of aseptic processing area at the Maple Grove 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 ofaseptic 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
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Required Qualifications:

• 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

Preferred Qualifications:

• 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

Maximum Salary: $ 188300

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.