MCS Manufacturing Associate

Actalent is hiring for a Manufacturing Associate in the Thousand Oaks area!

Job Description

The MCS Manufacturing Associate plays a key hands-on role in a regulated manufacturing environment, supporting the production of high-quality products through precise execution of procedures, operation of equipment, and adherence to cGMP and safety standards. This position involves setting up, operating, cleaning, and inspecting manufacturing equipment, preparing buffers and media, documenting work in real time, and collaborating closely with cross-functional teams to ensure safe, efficient, and compliant operations across various shifts.

Responsibilities

+ Set up, clean, sanitize, and inspect a variety of manufacturing equipment and process areas according to approved procedures and standards.

+ Prepare buffers and media following defined manufacturing procedures, master production records (MPs), and standard operating procedures (SOPs).

+ Follow GMP documents, including SOPs and MPs, with strict adherence to safety, compliance, and cGMP requirements at all times.

+ Perform and monitor critical manufacturing processes, conduct basic troubleshooting, and respond to alarms or unexpected conditions by following procedures and notifying appropriate support teams.

+ Perform in-process sampling of equipment and operate analytical equipment as required to support production activities.

+ Carry out washroom activities, including cleaning small and large-scale equipment used in production.

+ Maintain a safe, clean, and organized workspace and ensure process areas are kept in a state of readiness.

+ Work in a clean room environment while wearing appropriate protective attire, including steel toe shoes, full clean room gowning, hairnet, and gloves.

+ Initiate quality reports and support quality-related investigations as needed.

+ Draft, revise, and improve documents such as SOPs and MPs to reflect current practices and continuous improvement initiatives.

+ Identify, recommend, and implement improvements related to routine functions and manufacturing processes.

+ Assist in the review of documentation for assigned functions, including equipment logs and batch records, to ensure completeness and accuracy.

+ Perform manufacturing activities according to approved procedures, batch records, and cGMP requirements, including buffer preparation, chromatography, filtration, and UF/DF operations as applicable.

+ Complete batch documentation and electronic records accurately, thoroughly, and in real time.

+ Verify equipment status, materials, and documentation before and during operations to ensure readiness and compliance.

+ Monitor process parameters, record observations, and escalate issues promptly to Quality, Engineering, Automation, and other support groups.

+ Communicate process status, issues, and handoff details clearly to teammates and to the next shift to ensure continuity of operations.

+ Participate in training, qualification, and continuous improvement activities to maintain and enhance operational competence.

+ Collaborate with cross-functional teams, including Quality, Engineering, Automation, and other support groups, to keep manufacturing activities on track.

+ Perform activities that include periods of rigorous, repetitive work and work around high-pressure systems and heavy equipment while following all safety guidelines.

+ Work effectively within a team environment, contribute to a positive work culture, and support colleagues in completing operational tasks.

+ Remain available to work various shifts, including days, nights, weekends, and holidays, on 3x12 or 4x12 hour schedules as dictated by the production plan.

Essential Skills

+ Experience following SOPs, batch records, GMP, and cGMP requirements with strong…