Job Details
MILITARY VETERANS
Based at our new cGMP Manufacturing facility in Norwood, MA, this position will be responsible for maintenance and repairs of GMP/non-GMP process systems and support equipment. This position will also support troubleshooting, investigations, and reliability engineering for GMP/non-GMP process and support equipment. This position will be the first responder to equipment issues and must follow through to ensure resolution by either self-performing the work or directing the activities of service providers
Here s What You ll Do:
- Perform preventative and corrective maintenance activities to support process equipment and systems, in accordance with established procedures and/or approved practices. Support efforts in developing remediation for follow-up and emergency work.
- Troubleshoot equipment and systems, and repair malfunctioning equipment. Work with equipment owners/engineers and direct the performance of work by equipment vendors.
- Maintain cGMP records, both paper-based and electronic.
- Understand Asset Management and routine reliability concepts.
- Provide subject matter expertise for the operation and maintenance of manufacturing and support systems/equipment such as Process Air, Process Chilled Water, Nitrogen, Water for Injection (WFI) generation and distribution systems, autoclaves, washers, TFF, Chromatography Columns and skids, mixers, and stainless tanks.
- Maintain Facilities SOPs as required. Perform revisions and maintain author/owner responsibilities.
- Provide on-call support on a rotating basis. Support regular 24-7 operation of facility and respond to facilities issues as needed.
- Ensure that spare parts, tools, calibration standards and equipment are available to complete all assigned tasks.
- Respond to alarms and document activities in accordance with cGMP requirements. Working with equipment owners and develop remediation activities for alarms.
- Manage contract service providers; including scheduling, training on required SOP s, coordination and ensuring all work and documentation is performed in accordance with cGMP requirements.
- Administer and perform hazardous energy control procedures and confined space entry.
- Other duties as required.
Here s What You ll Bring to the Table:
- AS or BS degree in a science/technical field or a technical trade school preferred with 5-8 years of relevant experience working in a regulated (cGMP preferred) environment.
- Thorough understanding of OSHA regulations related to LOTO, MSDS, Confined Space and Hot Work.
- Military training equivalent of above is acceptable.
- Experience with Metrology.
- Understanding of PLC controls for simple troubleshooting is preferred.
- Excellent interpersonal and communication skills (verbal and written) are required. Ability to present own work to peers and cross-functional managers and influence leadership decisions.
- Technical writing skills required.
- Must have a customer service mindset.
- Must be able use technical expertise and judgement to investigate issues using a structured problem-solving approach t3o determine true root cause and path forward for complex problems.
- Demonstrated ability to learn new equipment/systems.
- Familiarity with Excel, Word, and PowerPoint.
- Ability to navigate computerized data and information management systems.
- Ability to interact well with other groups and must be able to take ownership of and follow through on assignments with minimal guidance.
- Must be able to drive results on multiple assignments simultaneously with minimal direction from management.
- Ability to represent Moderna s interests, objectives, and policies in a professional and responsible manner.
- Ability to work in fast-paced manufacturing environment.
- Respect for People.
- Ability to work collaboratively.
- Creative Problem Solving.
- Decision Making.
- Exemplary Work Ethic, Driven by the Mission.
- Impeccable Integrity.
- Risk Taking / Accountability.
- Humility.
- Mental Toughness.