Job Details
Location: Norwood, Massachusetts
Shift: 1st shift Wed-Sat (7AM 5PM or 6PM 4PM can be flexible) 5% differential
Compensation: $90,000 - $105,000
The Role
- Based at our new GMP Manufacturing facility in Norwood, MA, this position will be responsible for calibration, maintenance, and repairs of GMP/non-GMP process and support equipment. This position will also support troubleshooting, investigations, and reliability engineering for GMP/non-GMP process and support equipment in the Fill and Finish operation. 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 and calibrations 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 technical expertise for the maintenance and repair of manufacturing and support systems/equipment such as autoclaves, washers, formulation, vial/syringes lines, inspection, and label/packaging equipment.
- Perform calibrations in the following disciplines: Balances/scales, flow, temperature, conductivity, pressure, among others in a GMP/GXP environment.
- 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.
- Additional duties as may be assigned from time to time.
Here s What You ll Need (Minimum Qualifications)
- AS or BS degree in a science/technical field or a technical trade school preferred.
- Minimum 7 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.
Here s What You ll Bring to the Table (Preferred Qualifications)
- 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 to 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 The Company s interests, objectives, and policies in a professional and responsible manner.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.