The Aseptic Manufacturing Technician II role is crucial for the autologous cell therapy manufacturing program. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes. The Manufacturing Technician will be responsible for various tasks, such as cleaning, sanitization, preparation, and fulfilling products for commercial and clinical use. To excel in this role, it is strongly desired that the candidate has a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations. This position works across different shifts. Depending on your assigned shift, you may be required to work on weekends and holidays.
Essential Functions and Responsibilities
Develop a comprehensive understanding of and execute the company's 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.
Must adhere to the company's core values, policies, procedures, and business ethics.
Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
Perform miscellaneous duties as assigned.
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).
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
Mental:
Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Work Environment:
This position will work in both an office and a manufacturing lab setting. When in the lab, must be able to work in a Lab setting with various chemical/biochemical exposures, including latex and bleach, and potential exposure to noise and equipment hazards and strong odors.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They do not constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or change the position’s responsibilities at any time.
the company is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.
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
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