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Company

Original Job Post

American Regent, Inc. · 2 days ago

Process Engineering Development Lead

Brea, CA

Full-time

Hybrid

Senior Level

$89K/yr - $100K/yr

2+ years exp

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Responsibilities

Lead the process development of pharmaceutical drug product and oversee manufacturing activities within a cleanroom environment.

Plan and prepare process equipment skid setup for manufacturing processes.

Exercise critical thinking in investigation and troubleshooting experiments and process developments.

Schedule manufacturing campaigns and process qualifications around deadlines.

Initiate and update SOPs and other documents to ensure cGMP compliance.

Review and approve batch records and process qualifications.

Comply with and ensure all staff are practicing all safety policies and procedures.

Tracks metrics to discover areas for improvement and monitor upgrades.

Track equipment function and reliability.

Communicates findings and proposals to upper management.

Draft SOPs, forms, and other technical documents to ensure cGMP compliance.

Utilizes process simulation software to test and find the most appropriate production strategies.

Perform any other tasks/duties as assigned by management.

Qualification

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Pharmaceutical manufacturingCGMPManufacturing practicesLaboratory practicesEquipment operationStandard Operating ProceduresCleanroom protocolsPPERespirator useWorking in noisy environmentsProblem-solvingCommunicationFlexibility

Required

Bachelor’s or master’s degree in a STEM field.

2 or more years of pharmaceutical manufacturing experience required.

Must have knowledge of cGMP and should have necessary skills working in controlled environments.

Apply knowledge of good manufacturing practices and good laboratory practices on a daily basis.

Must have knowledge of concepts, procedures, and equipment common in pharmaceutical manufacturing.

Ability to multi-task and retain flexibility in a dynamic environment.

Well-developed written and oral communication skills.

Demonstrate good management skills.

Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.

Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.

Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.

Employee must be able to occasionally lift and/or move up to 25 pounds.

Employee is required to bend, sit, walk, work in noisy environments, able to work in small, and in unconditioned spaces.

Benefits

Healthcare

Life insurance

Profit sharing

Paid time off

Matching 401k

Company

American Regent, Inc.

American Regent, Inc, a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics and hospitals across the United States and Canada.

Founded in 1967

Shirley, New York, USA

501-1,000 employees

http://www.americanregent.com/

H1B Sponsorship

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2020 (7)