**Multiple levels available (level I through an aseptic lead)**
Years of experience will depend on pay and title
6-month CONTRACT TO HIRE
Shift A-Rotation-Confirmed
Week 1
- Sunday to Tuesday: 6:00PM – 6:30AM
Week 2
- Sunday to Wednesday : 6:00PM – 5:30AM
OR
Shift B-rotation-Confirmed
Week 1
- Wednesday to Saturday: 6:00PM – 5:30AM
Week 2
- Thursday to Saturday: 6:00PM – 6:30AM
Essential Functions and Responsibilities
- Develop a comprehensive understanding of and execute GMP proficiently.
- Cell therapy manufacturing process(es).
- Complete training sessions and ensure training documentation is maintained.
- Understand and comply with quality standards and requirements as documented.
- Provide operational support functions, including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
- Perform document review, including executed Batch Records and Logbooks.
- Support documentation needs, which include a review of SOPs, Batch Records, Deviations, CAPAs, etc.
- Supports technical transfer and additional research-level testing activities as needed.
- Perform basic revisions as needed to reflect current procedures accurately.
- Support departmental projects in a contributor capacity.
- May support training sessions as a qualified trainer, ensuring training documentation is maintained.
- Assists with identifying training needs, establishing a feedback loop to ensure continuous improvement.
- May work on moderately complex assignments, requiring judgment to resolve operational issues without negatively impacting manufacturing efforts.
- Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
- Attend the daily huddle meeting and escalates issues/concerns at that forum to Area Management for further investigation.
- Ability to work in a team environment and independently as required.
- Works on routine assignments per written procedures, where the ability to recognize deviation from accepted practice is required.
Travel - 5% travel, based on business needs.
Required Education, Skills, and Knowledge
- Bachelor's degree or some post-secondary education
- Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
- Ability to mentor and provide best practices to new techniquess.
- Must be able to deal with ambiguity – ready to change gears and plans quickly and manage constant change.
- Must read, write and understand English, especially for Good Documentation Practices, and be proficient in Microsoft (Excel, Word, Outlook).
- Ability to perform arithmetic calculations accurately and reproducibly, including fractions, decimals, percentages, and basic algebraic and geometric calculations.
- Ability to build relationships quickly and credibly
- Ability to work successfully in a fast-paced, team-oriented
Preferred Education, Skills, and Knowledge
- Minimum 1+ years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
- Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA
- Proactive, results-oriented, self-starter with experience in a complex manufacturing
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
For the Visual Inspection Program, the technician must be able to pass a Vision Exam that includes the following:
- Must not be color
- Must have 20/20 near vision in both eyes (can be corrected)
- Clarity of vision at near and mid-range, depth perception, and ability to identify and distinguish colors may be given a visual exam for visual acuity and color perception.
Physical Demands and Activities Required:
- Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
- Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps.
- Must meet requirements for and be able to wear a half-face respirator
- Able to work in a cleanroom with biohazards, human blood components, and chemicals.
- Able to crouch, bend, twist, reach, and perform activities with repetitive motion
- Must be able to lift and carry objects weighing up to 45 pounds
