HPV Fermentation Sr. Tech, Operations Night Shift

Job Description

Senior Technician Operations

Job Description

The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham NC. This stateoftheart facility established in 2004 manufactures our Company lifesaving vaccines in bulk and finished forms. Due to the importance of this facility in our Company Vaccine Manufacturing network the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1000 people.

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This position is in direct support of our Upstream Fermentation manufacturing process for Bulk Drug Substance. Focused areas of responsibility include but are not limited to activities of: Media Preparation Fermentation Tangential Flow Filtration Process Monitoring Sampling and area cleaning. As a Senior Technician you will be an energetic leader with strong interpersonal communication and collaboration skills responsible for supporting the manufacturing process. Individual will possess the ability to lead a small team train others and contribute to process improvements.

Responsibilities may include but are not limited to;

• Support operations production through startup 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. Ensures shipment criteria and timely availability and delivery.

• Performs general maintenance and assists or ability in troubleshooting of equipment independently

• Performs sampling/inprocess 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.

• Identifies and addresses compliance environmental safety and process deviations as appropriate while notifying appropriate personnel.

• Serves on safety quality and other committees as required.

• Actively participate on crossfunctional 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 sixsigma quality safety or environmental training/initiatives as required.

• Selfmotivated 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).

Education Minimum Requirement:

• High School Diploma/GED or higher

Minimum Required Experience and Skills:

• Minimum 2 years relevant work experience in GMP environment

• Demonstrated written and verbal communications skills

• Must be willing and able to lift 50 lbs and work on elevated platforms

• Must be willing to work 12hour shifts:

  • Night Shift position hours will be 7pm7am.

• Must be willing to work a 223 schedule (2 days on 2 days off 3 days on) which includes every other weekend.

Preferred Experience and Skills:

• Demonstrated 12 years of leadership experience

• 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 handson or instructorled training

• Experience with onthefloor cGMP manufacturing and familiarity with regulatory requirements

• Demonstrated ability to work both independently and as a part of a team

Travel: 0%

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