Senior Technician
4 weeks ago
This role is responsible for supporting the manufacturing process in our Downstream Purification department. As a Senior Technician, you will be an energetic leader with strong interpersonal, communication, and collaboration skills.
Key Responsibilities- Support operations production through start-up and commissioning and qualification through licensure and ramp up.
- Participate in document design activities working alongside operations team members to develop reliable, consistent manufacturing processes that meet cGMP requirements.
- Promote a culture of visibility and accuracy of the project schedule and update dashboards accordingly to highlight project status to critical milestones.
- Working in conjunction with all appropriate personnel, performs manual and automated operations, general maintenance and support functions necessary for the production.
- Provides and/or authors all documentation and clerical functions necessary to allow proper accountability and traceability of product.
- Maintains, inventories, and transports all required equipment, materials, supplies and products. Performs general maintenance and assists or ability in troubleshooting of equipment independently.
- Performs sampling/in-process testing supporting the manufacturing and validation process for current process.
- Provides timely delivery of sample and other materials as required to appropriate laboratories, coordinating with Quality and Logistics as required.
- Performs housekeeping in all work areas. Executes facility decontamination according to procedures. Maintains, cleans and prepares equipment used in production.
- Serves on safety, quality and other committees as required.
- Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process.
- Attends and actively participates in HAZOPS, waste walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required.
- Self-motivated to maintain own training status and ability to train others.
- Works independently, Trains others, and ability to trouble shoot, Subject Matter Expert in automated systems (SAP, MES, DeltaV).
- Minimum 3 years relevant work experience in GMP environment.
- Must be willing and able to lift 50 lbs and work on elevated platforms.
- Must be willing to work 12-hour shifts: If night position hours will be 7pm-7am.
- Minimum Associates Degree in science or related field.
- Applicable mechanical and project management experience.
- Proficiency with automated systems (MES, SAP, DeltaV).
- Experience training others and/or leading hands-on or instructor-led training.
- Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements.
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