Tech, Operations 2nd Shift Position Available In Durham, North Carolina

Tech, Operations 2nd Shift
Tech, Operations 2nd Shift
remote type
Not Applicable
locations
USA – North Carolina – Durham (Old Oxford)
time type
Full time
posted on
Posted 2 Days Ago
time left to apply

End Date:

July 3, 2025 (10 days left to apply)
job requisition id
R352798
Job Description
Our Manufacturing Operations teams are the people that make therapies for our patients. We work in the manufacturing plants with a “Safety First, Quality Always” mindset, striving for continuous improvement, and earn our right to produce. We work in local plants connected to our global manufacturing network supplying the highest quality of raw materials, intermediates, and finished products.
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.
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.
Responsibilities may include but are not limited to;
Project Support
Supports project team as operations expert through start-up,missioning, 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 addressespliance, 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 to meet production targets for area within 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 addressespliance, environmental, safety, and process deviations as appropriate while notifying appropriate personnel.

Education Minimum Requirement:

High School Diploma/GED or higher

Required Experience and Skills:

At least one (1) year GMP manufacturing/processing experience
Demonstrated written and verbalmunications skills
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
The position will be Mon-Fri, 2nd Shift (2:00pm-10:30pm)
Successfulpletion of TB titer and Chest X-ray are required. Preferred Experience and Skills (General):
Minimum Associates Degree in science or related field
BioWork Certificate (working in an FDA or similar regulated industry)
Applicable mechanical and project management experience
Experience with automated systems (MES, SAP, DeltaV, or similar)
Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements and Good Documentation Practices (GDP)
Demonstrated ability to work both independently and as a part of a team
The following experience is a significant advantage for a Technician supporting Product Support and Media (PSM) operations:
Experience operating Autoclaves and Parts Washers
Experience with Weigh and Dispense (W&D) and Formulation activities
Aseptic Behaviors
Aseptic Techniques & Manipulations MSJR #EBRG #VETJOBS TechniciaDurham