Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

 

	Consistently Ranked Science’s Top Employer Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we’ve been named the No. 1 company to work for in the biopharma industry in Science’s Top Employers survey for four years in a row.

 

A Certified Great Place to Work® We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

 

The Senior Process Engineer will play a key role within the Manufacturing Sciences Department, supporting clinical GMP drug substance and drug product production and quality control operations. This role combines technical leadership in equipment lifecycle management with oversight of calibration and maintenance systems to ensure operational readiness and regulatory compliance. Responsibilities include leading the procurement, installation, and qualification of instruments and equipment for GMP manufacturing and quality control (QC), with the flexibility to support both large-scale production systems and research and development equipment when needed. The role will also manage the Computerized Maintenance Management System (CMMS), ensuring timely scheduling of calibrations and maintenance, tracking new asset additions, and maintaining spare parts inventory and calibration standards. The individual will collaborate closely with the technical operations and quality teams to develop and implement robust calibration and maintenance plans, review executed certifications, and contribute to the creation of GMP-compliant documentation for site start-up and operational support.

• Serve as the SME for equipment lifecycle management in the GMP QC lab, with emphasis on commissioning, qualification (C&Q), validation, and equipment reliability.
• Design, procure, and upgrade QC equipment to align with site needs; assess equipment risk, obsolescence, and opportunities for productivity improvements.
• Develop and execute C&Q plans in compliance with internal procedures and regulatory standards.
• Lead CMMS implementation and maintenance, including asset setup, scheduling of calibration and
• maintenance events, and CMMS data integrity.
• Create and maintain calibration parameters, job plans, and maintenance work instructions; ensure alignment with GMP standards.
• Coordinate and oversee vendor services, obtain quotes, authorize work, and manage spare parts procurement.
• Collaborate with Manufacturing, QC, Facilities, and Engineering teams to resolve equipment issues, optimize maintenance plans, and drive continuous improvement.
• Lead or support cross-functional initiatives including maintenance shutdowns, equipment upgrades, and procedural training.
• Ensure all documentation, SOPs, and systems meet regulatory and internal compliance standards.
• Maintain strong analytical, documentation, and problem-solving skills to drive timely, independent decision-making and project completion.
• Proactively identify areas for improvement and contribute to a culture of operational excellence.

Requirements:

• Degree in science or engineering related field required.
• Bachelor’s Degree with 4+ years of experience or Master’s Degree with 2+ years of experience
• Experience in GMP environments and equipment lifecycle management
• Strong understanding of CMMS platforms and calibration/maintenance systems
• Ability to manage multiple priorities across QC and manufacturing operations
• Excellent collaboration and documentation skills
• Domestic and/or International travel required (10%)

$88,000 - $122,467 a year

At Insmed, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:

• Flexible approach to how we work
• Health benefits and time-off plans
• Competitive compensation package, including bonus 
• Equity Awards (Long-Term Incentives)
• Employee Stock Purchase Plan (ESPP)

 

For more information on U.S. benefits click here.

 

 

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

 

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

 

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

 

Applications are accepted for 5 calendar days from the date posted or until the position is filled.