Assoc. Tech, Operations
About The Position
This role is within an end-to-end facility that processes drug substance and drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse operations. The Associate Technician supports facility project activities through process performance qualification (PPQ), licensure, and ramp-up, and provides operational expertise to help meet production targets. The role involves working with equipment, facilities, consumables, and materials while maintaining compliance, safety, environmental standards, records, and housekeeping. The position is Monday through Friday on 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.
- Willingness and ability to lift 50 pounds, bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator.
- Successful completion of a TB titer and chest X-ray.
- Ability to use a respirator or powered air-purifying respirator occasionally for specific tasks.
- Ability to work Monday through Friday, 06:00–14:30, with occasional overtime as business needs dictate.
Nice To Haves
- Associate degree or higher in science or a related field.
- BioWork Certificate or experience working in an FDA-regulated or similar industry.
- Applicable mechanical and project management experience.
- Experience with automated systems such as MES, SAP, DeltaV, GLIMS, or similar.
- Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements and Good Documentation Practices (GDP).
- Demonstrated ability to work independently and as part of a team.
- Aseptic behaviors.
- Aseptic techniques and manipulations.
- cRAB/isolator experience.
- Environmental monitoring experience.
- Report review/approval and batch record review experience.
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 or notifying appropriate personnel.
- Participate in team meetings, HAZOPS, waste walkthroughs, 5S, kaizen events, and other operations, lean six-sigma, quality, safety, or environmental training and initiatives as required.
- Execute and own operational activities to meet production targets for the assigned area.
- Attend daily huddles and escalate concerns or needs as appropriate.
- Clean, set up, operate, and troubleshoot equipment and facilities.
- Maintain and transport consumable and material inventories.
- Maintain excellent recordkeeping and housekeeping.
- Promote continuous improvement and implement or raise ideas to improve group success.
- Participate in or perform technical and OPEX support activities, such as kaizen events, ad-hoc sampling, and protocol execution.
- Maintain detailed knowledge of equipment and processes.
Benefits
- Annual bonus and long-term incentive, if applicable.
- Medical, dental, and vision healthcare benefits.
- Other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays.
- Vacation.
- Compassionate and sick days.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
