Job Description
This role is within a end-to-end facility which includes the 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, 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 team as operations expert through PPQ, licensure and ramp up of facility.
- 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.
Education Minimum Requirement:
- High School Diploma/GED or higher
Required Experience and Skills:
- 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
- _This position will be Mon-Fri, day shift (06:00 - 14:30). Some overtime may be required as business needs dictate_
- Successful completion 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, GLIMS, 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 an
Associate Technician supporting Drug Substance operations:- Aseptic Behaviors
- Aseptic Techniques & Manipulations
- cRAB/Isolator Experience
- Environmental Monitoring
- Report review/approval and batch record review
