Lead GMP Reliability Engineer
Newark Metro Area, NJ
- Education & Experience:
BS degree in mechanical, electrical engineering or similar engineering field
Minimum 3-5 years of facilities maintenance/operations experience at an industrial or commercial site or related experience and/or equivalent combination of education and experience
2-5 years of GMP facility experience preferred
- Lead Facility & Reliability Engineer needed to implement a continuous improvement strategy to support the GMP Facilities to maintain a qualified and regulatory compliant Facility Operation status.
- Conducts Historical Performance Reviews on GMP Direct Impact assets and Critical instrumentation maintained and calibrated by the GMP Facilities Department
Initiates deviations for demand maintenance work orders or preventative maintenance activities that are out of compliance
Support and track deviations, investigations and CAPA plans for the GMP Facilities Department. Role will include conducting detailed investigations to determine root cause and necessary CAPAs by working cross functionally with Facility Management, QA, Validation and Business Area Management.
Implement predictive maintenance tools to identify equipment trending to failure to implement repairs prior to failure.
Support facility operations by providing operational SOPs to manage GMP facility and equipment operations. Procedures may include a USP Water System Operational Procedure or Facility Cleaning.
- Main responsibility will be to oversee the maintenance and calibration plans for all GMP and Non-GMP utility equipment and instrumentation.
- Lead small-scale capital and expense projects (20K to 250K) and coordinate large-scale capital projects with Global Engineering to support the GMP facility operations.
- The Lead Facility & Reliability Engineer supports the successful operation of facility, laboratory and business functions at multi-use GMP sites and represents the work group on multi-disciplinary and cross-functional teams and uses established relationships to influence and lead teams and stakeholders with fact-based, business value knowledge.