- Type: VMS
- Job #38728
Our Client, a global, science-led biopharmaceutical business is seeking a Associate Engineer to join their growing team. This is a great opportunity to work at a household name, get industry best training, and work with state of the art equipment, systems and products.
Main Duties & Responsibilities:
- This position will be responsible for providing on the floor manufacturing support for an assigned manufacturing area. This position will mainly focus on supporting the Downstream (Purification) areas.
- There may also be overlap supporting the Cell Culture operations (Harvest Tanks, Centrifuges, Bioreactors) and Support Services (Buffer Tanks, Autoclaves, and Parts Washers)
- Monitors equipment performance. Identifies equipment issues and develops technical solutions. Performs troubleshooting, maintenance, and process performance optimization. Supports shutdown and return to service activities.
- Equipment including Purification columns and skids, defiltration skids, stainless steel hold tanks, bulk fill operations, etc.
- Coordinates maintenance activities with Facilities / Coordinates service contracts and work of outside vendors. Writes, tracks, and executes SAP work orders, and creates and revises Preventative Maintenance plans.
- Provides input to continuous improvement activities, conducts root cause analysis and supports new product introduction. Participates in activities across Engineering function, helping ensure that agreed priorities are carried out and projects are delivered according to plan.
- Leads and participates in projects of varying sizes and complexity. Determines process requirements. Supports design, installation, and commissioning of new processes and equipment. Performs quality/safety investigations, and risk evaluations. Owns and executes Quality and Safety CAPAs. Independently performs GMP change control activities.
- Writes and reviews both cGMP and non-GMP documentation; including: SOPs, validation protocols, user requirements, specifications, JHAs, drawings, work instructions and reports
Education & Experience Requirements:
- BS/BA Engineering degree preferred. Associates degree and/or High School Diploma acceptable with sufficient experience
- 0-1 yrs. experience with Bachelor Engineer:
- BS/BA Engineering degree preferred. Associates degree and/or High School Diploma acceptable with sufficient experience 3 yrs. experience with Bachelors