Senior Maintenance Technician – Framingham, MA
Replimune is a fast-paced growing innovative company that is in the process of bringing on-line a brand-new production facility purposefully designed to manufacture our Oncolytic Immunotherapies. This multi-product facility in Framingham contains cGMP manufacturing for both drug substance and drug product, as well as process development laboratory space. The Senior Maintenance Technician will provide comprehensive maintenance, repair and service for facilities, utilities, systems and equipment (FUSE) at the Framingham cGMP manufacturing facility. Areas of responsibility include, but are not limited to, advanced installation, troubleshooting, maintenance, repair, testing, and documentation of maintenance activities. Experience working within FDA regulated environments (cGMP) and Environmental Health and Safety (EH&S) guidelines. Excellent interpersonal and communication skills (verbal and written) are required.
- Routine and complex preventive maintenance and repair on a variety of process equipment, building systems, central utilities and facility components and structures in compliance cGMP policies and procedures.
- In-depth and detailed maintenance work including installing, operating, and maintaining all equipment and systems that support the facility. These include HVAC systems, building management systems, chillers, boilers, emergency generators, compressed air, process gas distribution, pure water, WFI and clean steam systems.
- Installation, startup and maintenance of cGMP manufacturing process equipment.
- Oversee outside vendors and contractors to ensure work is performed and documented in compliance cGMP policies and procedures.
- Ensure that all in-house and vendor work activities are performed following EH&S guidelines.
- On call responsibilities to provide emergency support on an as needed basis.
Skills and experience:
- A minimum of 5 years relevant experience – preferably in a biotech pharmaceutical environment – required.
- Strong technical knowledge and practical experience in instrumentation, manufacturing equipment, building mechanical systems, emergency backup power equipment, including:
- Biological and chemical waste management.
- Confined space and lock out/tag out programs.
- Ability to understand and comprehend utility and system drawings.
- Working knowledge of automation software, PLC controllers, electrical motors, variable speed drives, pneumatic and gas systems.
- Preferred experience:
- Understanding of qualification and/or validation of facility equipment and utilities.
- cGMP documentation – Facilities documentation (work orders, equipment files, calibrations, developing SOPs) and QA systems (CAPAs, deviations, change controls)
- Working knowledge of Microsoft Office (Word, Excel, Outlook, etc.)
- Familiarity with Computerized Maintenance Management System (CMMS) to record GMP maintenance work activities
- Education, Licenses and Certifications:
- Post-secondary degree in a technical field or a technical trade school degree preferred.
- One or more of the following preferred:
- Massachusetts Journeyman Electrician
- Massachusetts Journeyman Plumber
- Massachusetts HVAC/Refrigeration Technician
- EPA Refrigerant Recovery Type I, II, III or Universal Certification
- Massachusetts Grade II Industrial Wastewater license (Required)
EEO & Employment Eligibility:
Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition.
Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.