Description Responsibilities • The MFG Associate I is responsible for the manufacturing of the drug substance and/or drug product portfolio • This includes support and collaboration with manufacturing customers and partners, including Quality, MSAT, Facilities, and management, that results in safe, high quality, and continuously improving production, while maintaining full compliance with current Good Manufacturing Practices, and corporate principles, quality policies, and standards • This position supports fermentation, purification (CLF), and aseptic fill suite (AFS) areas of manufacturing • Daily GMP Manufacturing operation activities in the cleanroom and AFS • Daily Manufacturing support, cleaning, autoclave and parts wash • Work closely with Manufacturing leadership team, MSAT, Quality, and Scheduling to meet short and medium term objectives • Responsible for escalations as needed • Drive a culture of continuous improvement • Develop area technicians in both expertise and production knowledge • Comply with cGMP and GDP regulations • Order and dispense raw materials • Perform inventory cycle counts and site fit-for-use inspections • Perform revision and creation of SOP’s, batch records, or associated protocols under a change control program • Perform deviation initiation, investigation, resolution, and CAPA • Maintain right-to-operate: Ensure cGMP production of products in compliance with all applicable Health Authority requirements and Quality Management System Maintain inspection readiness, and serve as an area SME during inspection tours • Ensure systems and processes are properly maintained to ensure staff’s safety, product quality, and continuity of supply • Ensure that staff are appropriately trained and qualified for the activities they perform prior to execution • Ensure on-site presence for their staff and themselves • Work overtime (including outside of normal business hours) as needed per business requirements Additional Skills & Qualifications • Bachelor’s degree, preferably in Life Sciences or engineering with 2-3 years of relevant work experience, or associates degree and 4+ years of relevant work experience, or high school diploma and 5+ years of relevant work experience • Knowledge of large molecule biopharmaceutical manufacturing processes and equipment • Ability to work on-site full-time as required • Ability to lift and carry up to 40 pounds • Work overtime as required, including outside of normal business hours • Ability to stand for a prolonged period operating manufacturing equipment, including in an ISO5 cleanroom Pay and Benefits The pay range for this position is $28.00 - $33.00/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• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Vacaville,CA. Application Deadline This position is anticipated to close on Mar 20, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.