Sr. Tech, Operations

Job Description

This role is within a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse.  As the team finishes design and construction of the facility, the Lead Technician will play a critical role in supporting the Global Engineering Services team, partnering with internal stakeholders, and building the operations team who will take ownership of the facility. Members of the Operations team in this new and exciting facility will have the unique opportunity to give input in the design process, startup their areas, and lead the teams to full production.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you.  To this end, we strive to create an environment of mutual respect, encouragement, and teamwork.  As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

NOTE: Position is 1st Shift (6:00am - 2:30pm), Monday - Friday

Position Responsibilities:

Project Support

• Supports project team as operations expert through start-up, commissioning, qualification through licensure and ramp up of facility.

• Author, review, and/or edit operations and technical documentation (Batch Records, SOPs, Job Aides, training, and engineering documents) to support project and future operations.

• Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while coordinating with appropriate personnel.

• Actively participate in team meetings HAZOPS, waste walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required.

Operational Expertise

• Competent execution and ownership of production targets within areas of responsibility including:

  • Attending and escalation of concerns or needs at daily huddles and as needed

  • Cleaning, setup, operation and troubleshooting of equipment and facilities

  • Maintenance and transportation of consumable and material inventories

  • Maintenance of excellent recordkeeping and housekeeping

• Drives culture of continuous improvement. Implements and raises ideas to increase success of group

• Participates on and/or performs activities to support technical and OPEX functions such as Kaizen events, ad-hoc sampling, or protocol execution.

• Maintains detailed knowledge of equipment and processes.

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

• Upholds and enforces proper cGMP standards across all disciplines in area of responsibility (e.g. using SOPs in performance of duties)

Education Minimum Requirement:

• High School Diploma/GED or higher

Required Experience and Skills:

• Bachelor’s degree in Life Science or Engineering and at least two (2) years GMP manufacturing/processing experience, or an Associate's degree in Life Science or Engineering and at three (3) years GMP manufacturing/processing experience

• Demonstrated written and verbal communications skills

• Must be able to successfully pass and maintain aseptic gowning qualifications. Aseptic gowning requires that all skin and hair be covered through wearing the following: beard/mustache cover, hair net, hood and facemask, goggles, jumpsuit, gloves, and boots

• Computer literacy (internet browsers, e-mail, spreadsheets, word processing)

• Must be willing and able to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator

• Serve as a trainer and source of knowledge to new and existing team members

• Successful completion of TB titer and Chest X-ray are required.  

Preferred Experience and Skills (General):

• Biowork Certificate (working in an FDA or similar regulated industry)

• Experience operating in a Grade C/D environment

• Experience worki