Sr. Downstream Processing Technician
7 days ago
Saint Louis
Job Description Job Title: Downstream Processing Technician III Job Description The Downstream Processing Technician III plays a key role in large-scale biological and chemistry pharmaceutical manufacturing by executing downstream processes in a cGMP-regulated cleanroom environment. This position focuses on flawless execution of manufacturing batch records, work instructions, and SOPs, while maintaining strict compliance with cGMP standards and safety guidelines. The role offers hands-on experience with biologics used in pharmaceutical products, providing an excellent opportunity to grow a career in the pharmaceutical and scientific research industry. Responsibilities • Execute manufacturing batch records, work instructions, and SOPs with a proactive focus on ‘right the first time’ performance., • Assist with batch record reconciliation to ensure accuracy and completeness of documentation., • Support all departmental functions by maintaining suites, supplies, equipment, logbooks, and data in accordance with site SOPs and policies., • Document all activities to meet cGMP requirements, including completing document reviews, revisions, daily record reviews, and database entries., • Actively provide feedback on documentation, processes, and procedures to support continuous improvement., • Participate in and at times lead shift exchanges, one-on-one discussions, and meetings to facilitate area needs and support lean activities., • Support quality investigations by answering questions, providing feedback, and making suggestions for process and system improvements., • Practice and promote safe work habits and strictly adhere to safety procedures and guidelines in all activities., • Critically evaluate processes with foresight, thinking ahead to identify potential issues and opportunities for improvement., • Ensure tasks are prioritized appropriately by interpreting production schedules and completing work in alignment with schedule requirements., • Work effectively within cleanroom and aseptic suites, following aseptic techniques and cleanroom procedures., • Bachelor’s degree (BS) in a STEM-related field required., • Minimum of 2 years of work experience in manufacturing, operations, production, laboratory setting, or a related field., • Ability to execute and follow detailed manufacturing batch records, work instructions, and SOPs., • Strong attention to detail with a proactive ‘right the first time’ mindset., • Ability to document activities clearly and accurately to meet cGMP requirements., • Capability to work in a cleanroom/aseptic suite environment and follow aseptic techniques., • Knowledge of or ability to learn cGMP practices, aseptic techniques, and basic chemical concepts., • Ability to interpret production schedules and prioritize tasks accordingly., • Commitment to safe work practices and adherence to safety procedures and guidelines., • Physical ability to lift a minimum of 25 pounds independently., • Preferred: Experience in a cGMP-regulated environment., • Preferred: 4-year STEM degree with exposure to aseptic technique, chemistry, chromatography, and related laboratory methods., • Preferred: At least 6 months of experience in a GMP-regulated environment and hands-on aseptic technique., • Experience or coursework in chemistry, HPLC, and pharmaceutical or biopharmaceutical industry processes is beneficial., • Familiarity with downstream processing steps and ability to grow into a subject matter expert role is preferred., • Strong communication skills to participate in shift exchanges, meetings, and cross-functional discussions., • Ability to provide constructive feedback and suggestions for process and documentation improvements. This role is based in a cleanroom and aseptic suite environment where you will work with large-scale biological and chemistry pharmaceutical operations that produce biologics, such as proteins used in pharmaceuticals for conditions like autoimmune diseases. You must be willing and able to meet full cleanroom gowning requirements, including wearing a full gowning suit consisting of a bodysuit, gloves, hair and beard nets, face covers, and safety glasses. Tyvek garments and Nitrile and/or Latex gloves are standard, and items such as makeup, jewelry, nail polish, cologne/perfume, and scented lotions or hair care products are not permitted in the cleanroom. The position begins with Monday–Friday training on first shift for approximately 4–6 weeks, focusing on SOP and safety training, followed by transition to 12-hour shifts for continued on-the-job training. The schedule then moves to 10-hour shifts on a 3-2-2-2-3-2 schedule, typically aligning with second shift hours around 2:00 p.m. to 12:00 a.m. There are rotating 12-hour day and night shifts, with night shifts running approximately 6:00 p.m. to 6:45 a.m., and a rotating two-week pattern where you work 7 days out of 14 (Week 1: work Monday–Tuesday, off Wednesday–Thursday, work Friday–Sunday; Week 2: off Monday–Tuesday, work Wednesday–Thursday, off Friday–Sunday). The environment is fast-paced, highly regulated, and team-oriented, with a strong emphasis on safety, quality, and adherence to cGMP standards. This position requires standing for most of the shift and handling materials up to 25 pounds, offering significant exposure to advanced biopharmaceutical manufacturing processes and opportunities for career growth in a world-class scientific operation. INTERESTED IN THIS ROLE? SEE BELOW TO BE IMMEDIATELY CONSIDERED I am scheduling Phone Interviews as Early as Today. All candidates will be interviewed within 48 Hours of applying directly to Nischitha Prakash. 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 - $32.20/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.