Manufacturing Operations Technician - Durham, NC Oxford

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.

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

• High School Diploma/GED or higher.

• At least one (1) year 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.
• The position will initially be Mon-Fri, day shift. Must be willing to work various shift schedules as required when operations start.
• Successful completion of TB titer and Chest X-ray are required.

• Minimum associate's degree in science or related field.
• Bio-Work Certificate (working in an FDA or similar regulated industry).
• Applicable mechanical and project management experience.
• Experience with automated systems (MES, SAP, Delta
  
  V, 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.

• Aseptic filling operations.
• Grade A isolator containment systems.
• Lyophilization.
• Visual inspection of product in glass vials including manual & automated techniques.
• Experience with autoclaves, washers, and dry heat ovens.

Up to 5% of the time.

• Shift: 1st - Day
• Relocation:
  No relocation
• Visa Sponsorship:
  No
• Travel Requirements: 10%
• Flexible Work Arrangements:
  Not Applicable
• Valid Driving License:
  No
• Hazardous Material(s):
  Cleaning Supplies
• Employee Status:
  Regular

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under the U.S. Equal…