Associate Technician Operations

MSD • Durham, NC

4d

About The Position

The Associate Technician Operations role supports operations at an end-to-end facility that processes drug substance and drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse functions. The role supports facility process qualification, licensure, and ramp-up, and contributes to safe, compliant, reliable production and continuous improvement. The position is Monday through Friday on the day shift, 06:00–14:30, with occasional overtime as business needs dictate.

Requirements

• High school diploma/GED or higher.
• Demonstrated written and verbal communication skills.
• Successfully pass and maintain aseptic gowning qualifications. Required gowning covers skin and hair and includes a beard/mustache cover, hair net, hood, facemask, goggles, jumpsuit, gloves, and boots.
• Computer literacy, including internet browsers, email, spreadsheets, and word processing.
• Able and willing to lift 50 pounds; bend, stoop, squat, crawl, twist, and climb ladders; and wear a respirator.
• Successful completion of a TB titer and chest X-ray.
• Willingness to use a respirator or Power Air Purifying Respirator occasionally for specific tasks.
• Work Monday through Friday, day shift (06:00–14:30); occasional overtime may be required as business needs dictate.

Nice To Haves

• Associate degree or higher in science or a related field.
• BioWork Certificate.
• Experience working in an FDA- or similarly regulated industry.
• Applicable mechanical and project management experience.
• Experience with automated systems such as MES, SAP, DeltaV, or GLIMS, or similar systems.
• Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements and Good Documentation Practices (GDP).
• Ability to work independently and as part of a team.
• For Drug Substance operations support: aseptic behaviors, aseptic techniques and manipulations, cRAB/Isolator experience, environmental monitoring report review/approval, and batch record review.

Responsibilities

• Support the team as an operations expert through PPQ, licensure, and facility ramp-up.
• Identify and address compliance, environmental, safety, and process deviations, coordinating with and notifying appropriate personnel.
• Participate in team meetings, HAZOPs, waste walkthroughs, 5S and kaizen events, and other operations, lean six-sigma, quality, safety, or environmental initiatives and training as required.
• Meet production targets for the area of responsibility, attend daily huddles, and escalate concerns or needs.
• Clean, set up, operate, and troubleshoot equipment and facilities.
• Maintain and transport consumable and material inventories.
• Maintain excellent records and housekeeping.
• Promote continuous improvement by implementing and raising ideas to increase group success.
• Participate in or perform activities supporting technical and OPEX functions, such as kaizen events, ad-hoc sampling, and protocol execution.
• Maintain detailed knowledge of equipment and processes.

Benefits

• Medical, dental, and vision healthcare benefits.
• Other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED