Process Engineer - Pharma

Job Responsibilities:

Responsibilities include but are not limited to:

Process Optimization & Manufacturing Support

Provide day-to-day engineering support to pharmaceutical manufacturing operations.

Analyze manufacturing processes to identify opportunities for improving efficiency, quality, yield, and cost.

Troubleshoot process issues and implement corrective and preventive actions (CAPAs).

Monitor process performance through data analysis and key performance indicators (KPIs).

Lead root cause investigations related to process deviations, nonconformances, and customer complaints.

Validation & Compliance

Support process validation, equipment qualification, and revalidation activities.

Develop and execute validation protocols, reports, and technical documentation.

Ensure compliance with FDA regulations, cGMP requirements, BD policies, and applicable quality standards.

Support internal and external audits, inspections, and regulatory commitments.

Maintain manufacturing documentation, standard operating procedures (SOPs), and work instructions.

Continuous Improvement

Lead Lean Manufacturing and Continuous Improvement projects.

Utilize Six Sigma, DMAIC, and problem-solving methodologies to eliminate waste and improve process capability.

Identify and implement productivity, quality, and cost-reduction initiatives.

Participate in site transformation and operational excellence programs.

Project Management

Support new product introductions, technology transfers, and process changes.

Coordinate engineering projects from conception through implementation.