SHL Medical
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Facilities Engineer
role at
SHL Medical
Completed 4 days ago. Be among the first 25 applicants.
SHL Medical is a world‑leading provider in the design, development, and manufacturing of advanced self‑injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.
Job Overview The Facilities Engineer is responsible for the maintenance, reliability, and compliance of all facility systems that support manufacturing, laboratory, and office operations in an FDA‑regulated environment. This role ensures that building utilities, HVAC systems, refrigeration, compressed air and other critical infrastructure operate efficiently, safely, and in accordance with applicable regulatory and quality standards (e.g., FDA cGMP, ISO, and OSHA).
Main Responsibilities
Facilities and Utilities Management
Support and monitor preventive maintenance (PM) programs for facility and utility systems to ensure reliability and compliance.
Support calibration and qualification activities related to facility and utility systems.
Regulatory Compliance & Documentation
Ensure facilities meet FDA, GMP, and other regulatory requirements.
Maintain accurate and complete engineering and maintenance documentation including equipment files, change controls, deviation reports, and CAPAs.
Update/Develop Facility related to QWI’s and QOP’s.
Generate/Close Change Controls, Investigations, and CAPAs related to the Facilities GMP requirements.
Serve as SME for SAP related activities and provide training to facilities personnel.
Serve as a liaison between QA and Facilities.
Participate in internal and external audits and inspections; provide documentation and responses as needed.
Project Engineering
Lead or support capital projects for facility upgrades, expansions, or equipment installations.
Support creation of user requirements, design specifications, and validation protocols.
Manage contractors, vendors, and service providers to ensure safe and compliant work execution.
Environmental Health & Safety (EHS)
Support compliance with local, state, and federal safety regulations.
Conduct risk assessments and implement corrective and preventive measures to maintain a safe workplace.
Continuous Improvement
Identify and implement process improvements to enhance facility efficiency, sustainability, and reliability.
Support lean manufacturing and energy conservation initiatives.
Performs other related duties as assigned.
Skills and Qualifications
Associate’s degree in engineering (Mechanical, Electrical, Chemical, or related field), at a minimum.
2–5 years of experience in facilities or utilities engineering, preferably in an FDA‑regulated (pharmaceutical, medical device, or biotech) environment.
Strong knowledge of cGMP, FDA, and ISO 13485 regulations.
Experience with cleanroom environments, HVAC design, and critical utility systems preferred.
Proficiency with CMMS systems and building automation systems (BAS/BMS).
Excellent problem‑solving, troubleshooting, and project management skills.
Strong written and verbal communication skills.
We Offer
Competitive compensation package.
Modern working environment with state‑of‑the‑art facilities and technologies.
Challenging assignments in a fast growing and innovative industry.
Position in a dynamic, international team of highly skilled professionals.
Various opportunities for personal and professional development within a global organization.
Please note that SHL is a drug free employer. This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check.
For more information on SHL Medical, please visit:
shl-medical.com
Additional Information
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Management and Manufacturing
Industry: Medical Device
Referrals increase your chances of interviewing at SHL Medical by 2x.
#J-18808-Ljbffr
Facilities Engineer
role at
SHL Medical
Completed 4 days ago. Be among the first 25 applicants.
SHL Medical is a world‑leading provider in the design, development, and manufacturing of advanced self‑injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.
Job Overview The Facilities Engineer is responsible for the maintenance, reliability, and compliance of all facility systems that support manufacturing, laboratory, and office operations in an FDA‑regulated environment. This role ensures that building utilities, HVAC systems, refrigeration, compressed air and other critical infrastructure operate efficiently, safely, and in accordance with applicable regulatory and quality standards (e.g., FDA cGMP, ISO, and OSHA).
Main Responsibilities
Facilities and Utilities Management
Support and monitor preventive maintenance (PM) programs for facility and utility systems to ensure reliability and compliance.
Support calibration and qualification activities related to facility and utility systems.
Regulatory Compliance & Documentation
Ensure facilities meet FDA, GMP, and other regulatory requirements.
Maintain accurate and complete engineering and maintenance documentation including equipment files, change controls, deviation reports, and CAPAs.
Update/Develop Facility related to QWI’s and QOP’s.
Generate/Close Change Controls, Investigations, and CAPAs related to the Facilities GMP requirements.
Serve as SME for SAP related activities and provide training to facilities personnel.
Serve as a liaison between QA and Facilities.
Participate in internal and external audits and inspections; provide documentation and responses as needed.
Project Engineering
Lead or support capital projects for facility upgrades, expansions, or equipment installations.
Support creation of user requirements, design specifications, and validation protocols.
Manage contractors, vendors, and service providers to ensure safe and compliant work execution.
Environmental Health & Safety (EHS)
Support compliance with local, state, and federal safety regulations.
Conduct risk assessments and implement corrective and preventive measures to maintain a safe workplace.
Continuous Improvement
Identify and implement process improvements to enhance facility efficiency, sustainability, and reliability.
Support lean manufacturing and energy conservation initiatives.
Performs other related duties as assigned.
Skills and Qualifications
Associate’s degree in engineering (Mechanical, Electrical, Chemical, or related field), at a minimum.
2–5 years of experience in facilities or utilities engineering, preferably in an FDA‑regulated (pharmaceutical, medical device, or biotech) environment.
Strong knowledge of cGMP, FDA, and ISO 13485 regulations.
Experience with cleanroom environments, HVAC design, and critical utility systems preferred.
Proficiency with CMMS systems and building automation systems (BAS/BMS).
Excellent problem‑solving, troubleshooting, and project management skills.
Strong written and verbal communication skills.
We Offer
Competitive compensation package.
Modern working environment with state‑of‑the‑art facilities and technologies.
Challenging assignments in a fast growing and innovative industry.
Position in a dynamic, international team of highly skilled professionals.
Various opportunities for personal and professional development within a global organization.
Please note that SHL is a drug free employer. This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check.
For more information on SHL Medical, please visit:
shl-medical.com
Additional Information
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Management and Manufacturing
Industry: Medical Device
Referrals increase your chances of interviewing at SHL Medical by 2x.
#J-18808-Ljbffr