Manufacturing Specialist

Aptask Global Workforce (AGW) is seeking a Manufacturing Specialist for an Onsite position with a Global Biotechnology Company located in Thousand Oaks, CA. This is a 12+ month contract opportunity.
The ideal candidate will have experience in a biotech or pharmaceutical manufacturing environment, with a strong preference for upstream operations. This position supports manufacturing from a process owner's perspective and requires a hands-on approach to troubleshooting, process optimization, and the implementation of new technologies. The role involves leading cross-functional projects and ensuring adherence to GMP standards.
Responsibilities:

• Support manufacturing by providing subject-matter expertise for Drug Substance Upstream and Downstream processes as a Process Owner
• Lead cross-functional and complex projects using project management skills
• Resolve issues and lead troubleshooting, including the execution of function tests to optimize processes
• Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management
• Own Quality Records, such as CCMS, CAPA, and CAPA-EV
• Apply technical, scientific, operational, and compliance knowledge to support the implementation of new technologies into the plant
• Support operational readiness of new technologies, equipment, or processes
• Develop and own drug substance manufacturing processes and procedures, including drafting and revising GMP documents (SOPs, Forms)
• Draft and develop user requirements for new technologies

Requirements:

• Bachelor's degree and 4 years of experience OR Master's degree and 2 years of experience OR Associate's degree and 8 years of experience OR High school diploma/GED and 10 years of experience
• At least 1 year of relevant experience in a biotech or pharmaceutical manufacturing environment
• Ability to adapt to changing priorities in a fast-paced environment
• Must be able to work 100% onsite, Monday-Friday during regular business hours, with flexibility for occasional non-standard hours (early, late, or weekend)
• Ability to work in a clean room environment following all GMP and safety protocols

Desired skills:

• Degree in Engineering or Life Sciences
• 3 or more years of experience in Drug substance GMP technical support roles, GMP manufacturing, Engineering, or Process Development
• Technical knowledge of drug substance processing
• Experience leading and managing projects
• Understanding of single-use technologies
• Strong communication skills, with experience presenting technical information
• Proficiency in Smartsheet, Excel, Trackwise, Visio, PI, SAP, or Spotfire

Pay range: up to $38.46 per hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position.
If you have the described qualifications and are interested in this exciting opportunity, apply today!
Aptask Global Workforce (AGW)
ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include:

• Medical
• Dental
• Vision
• Sick Pay (for applicable states/municipalities)

Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.