Work Schedule
Standard (MonFri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Office
Job Description
How will you make an impact
The Engineer III fulfills several key functions within the team; Management of quality records and compliance tasks for the department management and tracking of work orders and workflow for the sites fit and finish program GMP documentation support for capital projects and SAP/CMMS support for the team. The Engineer III role is part of the Engineering team and reports to the Manager of Manufacturing Engineering.
What will you do
- Manage contractors and small projects up to $1MM.
- Track scope schedule and budget for projects as required.
- Track all quality records for the engineering department to ensure ontime completion for all records.
- Support initiation of new quality records as required for engineering / capital projects.
- Drive closure of intermediate tasks on quality records to ensure departmental compliance/ontime completion.
- Track metrics and workflow of fit and finish program.
- Support routine fit and finish inspections of the facility.
- Support coordination of external contractors to complete work in the production suites.
- Serve as departmental SME on CMMS usage for creating tracking and closing work orders for work performed within the engineering department.
- Serve as a primary point of contact during audits (internal external regulatory) and work with the compliance team to provide timely accurate information to support audit requests related to facilities and engineering.
- Support the authoring of GMP documents as required to support engineering department objectives.
- Support start up and commissioning activities on capital projects as the need arises.
How will you get here
- Bachelors Degree or higher education in Engineering (Chemical Mechanical Electrical Bio) and 5 years experience.
- Associates Degree and 8 years of related professional experience.
- GED and 10 years of related experience.
- 3 years of pharmaceutical industry experience or experience in a similar industry
- Past experience managing work orders in SAP or equivalent CMMS software.
- Past experience managing contractors and projects up to $1MM
Knowledge Skills Abilities
- Excellent written and verbal communication
- Strong attention to detail
- Proficient with Microsoft Office Tools
- Experience using CMMS software to manage work.
- Experience authoring documents in a GMP setting.
- Experience working in a cleanroom.
- Prior experience working on commissioning and validation in a pharmaceutical setting.
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