Process Engineer – GMP/DEA Compliance

Sun Pharmaceutical Industries; Colorado; On-site; USD 103,000 - 115,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401(k) Savings Plan

Flexible Spending Accounts

Employee Assistance Program

Paid Time Off

Job summary

Sun Pharmaceutical Industries is seeking a Process Engineer to design and optimize manufacturing processes for APIs and intermediates. The role emphasizes cost-effective solutions, validation, and cross-functional collaboration with Quality, Operations and Technical Services.

The ideal candidate has a Bachelor's in Chemical Engineering and at least 5 years of experience in a regulated pharmaceutical environment, with strong project management, documentation, and analytical skills.

Qualifications

• Bachelor's degree in Chemical Engineering or related engineering discipline.
• 5+ years in a regulated manufacturing environment.
• Strong organizational and multi-priority management.
• Effective communication of technical concepts to all levels of the organization.
• Knowledge of GMP and FDA regulations.
• Experience with QA, change control, and process validation.

Responsibilities

• Prepare, review, approve and distribute production instructions.
• Produce APIs and intermediates according to approved procedures.
• Review batch records and ensure completion and sign-off.
• Investigate deviations and ensure critical deviations are addressed.
• Ensure facilities are clean and calibrated.
• Review validation protocols and reports.
• Lead process improvement and implement changes to optimize manufacturing.
• Manage assigned projects to meet deadlines and budget.
• Provide training for API processes.
• Perform other duties as assigned.

Skills

Process engineering

Project management

Cross-functional collaboration

Regulatory knowledge

Communication

Education

Bachelor's degree in Chemical Engineering

Tools

DCS (Distributed Control Systems)

Job description

Sun Pharmaceutical Industries is seeking a Process Engineer to design and optimize manufacturing processes for APIs and intermediates. The role emphasizes cost-effective solutions, validation, and cross-functional collaboration with Quality, Operations and Technical Services.

The ideal candidate has a Bachelor's in Chemical Engineering and at least 5 years of experience in a regulated pharmaceutical environment, with strong project management, documentation, and analytical skills.