Upstream Processing Technician
2 days ago
Saint Louis
Job Description Job Title: Upstream Processing Technician Job Description The Upstream Processing Technician supports the manufacture of commercial and clinical biologic products by executing upstream (cell culture) operations in a cGMP-regulated environment. Working in cleanroom and aseptic suites, this role focuses on mammalian cell culture, large-scale bioreactor operations, and associated filtration or centrifugation steps, while maintaining strict compliance with procedures, documentation standards, and safety guidelines. Responsibilities • Execute manufacturing batch records, work instructions, and standard operating procedures (SOPs) with a strong focus on proactive, right-the-first-time performance., • Assist with batch record reconciliation to ensure accurate and complete documentation of production activities., • Perform upstream processing activities, including propagation of mammalian cell cultures and aseptic cell culture operations., • Operate and monitor large-scale production bioreactors ranging from 50L to 2000L, following established parameters and procedures., • Conduct large-scale filtration or centrifugation operations as part of upstream processing workflows., • Support all department functions, including maintaining production suites, supplies, equipment, logbooks, and data in accordance with site SOPs and policies., • Document all activities in compliance with cGMP requirements, ensuring timely and accurate completion of records and logs., • Complete daily record reviews, assigned tasks, and updates in relevant databases to support ongoing production and quality needs., • Participate in document reviews and revisions to keep procedures, batch records, and related documentation current and effective., • Participate and, when needed, lead shift exchanges, one-on-one discussions, and team meetings to communicate status, issues, and changes impacting operations., • Engage in lean activities and continuous improvement efforts to enhance efficiency, quality, and safety in the manufacturing area., • Support quality investigations by providing clear information, answering questions, and suggesting improvements to processes and procedures., • Promote and follow safe work habits, adhering to all safety procedures, guidelines, and cleanroom practices., • Critically evaluate processes with foresight, identifying potential issues before they occur and recommending preventive actions., • Interpret production schedules, prioritize tasks effectively, and complete work in alignment with operational timelines and goals., • Lift and move materials or equipment up to 25 lbs independently as needed for production activities., • Remain on your feet for the majority of the shift to support continuous manufacturing operations., • Minimum of 2 years of work experience in manufacturing, operations, production, laboratory setting, or a related field., • High school diploma or equivalent., • Ability to apply critical thinking and problem-solving skills to identify, analyze, and resolve issues in a production environment., • Strong math skills to support calculations, measurements, and data interpretation in manufacturing processes., • Proficiency with MS Office applications for documentation, data entry, and communication., • Practical ability to recognize problems developing, not just problems that have already occurred, and take appropriate action., • Ability to read, write, and communicate effectively in English to follow instructions, complete documentation, and collaborate with team members., • Ability to understand and carry out written and verbal instructions accurately and consistently., • Willingness and ability to wear full cleanroom gowning, including bodysuit, gloves, hair and beard nets, face covers, and safety glasses, for extended periods., • Ability to meet cleanroom gowning requirements, including the use of Tyvek garments and Nitrile and/or Latex gloves., • Ability to lift a minimum of 25 lbs independently., • Bachelor’s degree in a STEM-related field, such as biology, chemistry, biochemistry, or a related scientific discipline, is preferred., • Experience in a cGMP-regulated environment is preferred, including familiarity with regulated documentation and quality systems., • Knowledge of cGMP practices, aseptic techniques, or chemical concepts is preferred., • Experience or subject matter expertise in upstream processing steps, including cell culture and bioreactor operations, is preferred., • Experience with aseptic technique, cell culturing, and pipetting in a laboratory or production setting., • Exposure to chromatography and biochemistry processes within pharmaceutical or biologics manufacturing is beneficial., • Preferred experience of at least 6 months in a GMP-regulated environment with hands-on aseptic technique., • Experience in the pharmaceutical or biopharmaceutical industry, especially in large-scale biologics production, is advantageous. This role is based in cleanroom and aseptic production suites that support large-scale biologics and chemistry operations. Technicians work around mammalian cell culture systems, bioreactors ranging from 50L to 2000L, and associated equipment for filtration, centrifugation, and chromatography. The position follows a 12-hour rotating shift schedule, with day shift from 6:45 a.m. to 6:45 p.m. and night shift from 6:45 p.m. to 6:45 a.m., working 7 days out of a 2-week period. A typical two-week rotation includes working Monday–Tuesday, off Wednesday–Thursday, working Friday–Sunday in week one, then off Monday–Tuesday, working Wednesday–Thursday, and off Friday–Sunday in week two. The environment requires full cleanroom gowning, including a bodysuit, gloves, hair and beard nets, face covers, and safety glasses, as well as Tyvek garments and Nitrile and/or Latex gloves. Items such as makeup, jewelry, nail polish, cologne or perfume, and scented lotions or hair care products are not permitted in controlled areas. The work involves standing for approximately 80% of the shift and lifting up to 25 lbs independently. This setting offers a strong opportunity to gain experience in large-scale biologics manufacturing, contributing to the production of proteins and other biologic materials used in pharmaceutical products, including therapies for autoimmune and other diseases. Job Type & Location This is a Contract to Hire position based out of Saint Louis, MO. Pay and Benefits The pay range for this position is $28.00 - $28.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program • Hiring diverse talent, • Maintaining an inclusive environment through persistent self-reflection, • Building a culture of care, engagement, and recognition with clear outcomes Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.