Nature and Scope

The Process Development Engineer Lead will work closely with the manufacturing, and quality department to develop process for new equipment, improve existing process for safety, reliability, and efficiency inside and outside the clean room.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• 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.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability 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.

Physical Environment and Requirements

• 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.

Expected Salary Range:

$89,100-$100,00

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

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