Biopharmaceutical Manufacturing Specialist

4 weeks ago


Newbury Park, California, United States Actalent Full time
Job Summary

The Manufacturing Associate will work in a dynamic production environment supporting development, clinical, and launch activities. Under general supervision, the employee will perform operations in the Manufacturing area. Operations will be performed according to Standard Operating Procedures (SOPs).

Responsibilities:
  • Hands-on operations: set-up, cleaning, and sanitization of various manufacturing equipment
  • 100% manual inspection per defined manufacturing procedures (MPs) and standard operating procedures (SOPs)
  • Testing of drug product in-process/release samples per defined methods and SOPs
  • Following GMP documents (SOPs, MPs) with strict adherence to safety and compliance
  • Performing and monitoring critical processes with the ability to perform basic troubleshooting
  • Performing in-process sampling of equipment and operating analytical equipment
  • Performing inspection activities of filled containers
  • Maintaining an organized and clean workspace
  • Working in a GMP room environment, full clean room gowning, hairnet and gloves when performing all work
  • Initiating quality reports
  • Drafting and revising documents (SOPs, MPs)
  • Identifying, recommending, and implementing improvements related to routine functions
  • Assisting in the review of documentation for assigned functions (equipment logs, batch records)
  • Performing activities that include periods of rigorous, repetitive work
  • Working around high-pressure systems and occasionally work around heavy equipment
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.



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