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Location

Thousand Oaks, CA | United States

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Job description

Are you a dynamic professional with a passion for contributing to the pharmaceutical, biotech, medical devices, and manufacturing industry? We are seeking a talented and highly motivated Senior Manufacturing Associate to join our enthusiastic team. In this role, you'll be a crucial part of our world-class manufacturing operations in Puerto Rico & the USA.

Responsibilities:

Perform precise electronic data entry following Standard Operating Procedures (SOP).
Create and validate electronic batch records (EBR) using Manufacturing Execution System (MES) and ERP.
Support the transition from paper to electronic batch record processes.
Translate and comprehend process specifications from development teams into user-friendly source documents.
Create Parameter Value Lists in EBR.
Edit and create GMBRs in EBR.
Translate instructions from paper sources to electronic systems.
Provide internal support operations such as data verification, document management, and SOP revisions.
Focus on Manufacturing support, including EBR generation, editing, real-time troubleshooting, and managing EBR validation for new or modified processes.
Assist in the implementation of new MES functionality.
Participate and contribute to projects introducing new products and manufacturing technologies.
Communicate effectively with manufacturing, PD, supply chain, and QA teams.
Qualifications:

Bachelor's degree in engineering or Biological Sciences.
2+ years of experience in drug product/manufacturing.
Previous experience in biopharmaceutical manufacturing.
Significant experience with PAS X, Werum software for electronic batch records with understanding of editing and validation.
Ability to revise/create PVLs, GMBRs, ESPs.
Proficient in troubleshooting support.
Provide assessments for projects and NPIs.
Remote position (Pacific time zone preferred or ability to maintain Pacific hours).
We are an equal opportunity employer, promoting diversity and inclusion. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Employment Type: Full-Time
Salary: $ 32.00 Per Hour

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