Pharma Process Engineer - Scale-Up & Process Excellence

Perrigouk; New York (NY); On-site; USD 95,000 - 120,000; Full time

Benefits offered by this job

Competitive compensation

Career development opportunities

Forbes America\u2019s Best Employers -

Job summary

Perrigo in New York, NY is seeking a Process Engineer to provide technical and scientific support for Rx, OTC, and cosmetic topical products, working with Regulatory Affairs, Quality, R&D, Operations and Legal to develop, transfer and validate manufacturing processes.

You will support scale-up, investigate deviations, implement CAPAs, and ensure product quality and regulatory compliance. This role offers opportunities for growth within a collaborative, inclusive culture.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences or related field; 2–5 years in regulated pharma manufacturing.
• Strong knowledge of cGMP, FDA regulations, and pharmaceutical quality systems.
• Excellent communication, organization, and problem-solving skills.

Responsibilities

• Conduct technical assessments and provide process support for Rx, OTC, and cosmetic topical products to ensure quality, efficiency, and compliance.
• Lead technology transfer activities for newly developed products and transferred manufacturing processes from R&D or external sites into commercial operations.
• Develop, optimize, and implement manufacturing processes for new, existing, reformulated, and transferred products to improve process robustness, efficiency, and product quality.
• Investigate manufacturing issues, process deviations, and product failures; perform root cause analyses and recommend CAPAs.
• Review, revise, and maintain Manufacturing Orders, Ingredient Disclosures, Excipient Threshold Limits, cleaning procedures, and related docs for regulatory compliance and improvements.
• Perform lab-scale formulation and process development studies to support optimization, troubleshooting, and scale-up.
• Evaluate process performance data and identify opportunities for improvements and cost reduction.
• Support MRB activities and nonconforming materials disposition.
• Participate in PEM, PPQ, CPV/CV, and other validation activities to keep processes in control.
• Collaborate with Regulatory, Quality Assurance, R&D, Operations, and Legal to support lifecycle management and compliance with cGMP and FDA requirements.
• Prepare technical reports, protocols, investigations, and documentation for process changes, validation and regulatory submissions.
• Manage multiple projects with timelines and business objectives.

Skills

Process engineering

Pharmaceutical manufacturing knowledge

Regulatory compliance

Data analysis

Cross-functional collaboration

Technical writing

Education

Bachelor's degree in Pharmaceutical Sciences or related field

Tools

SAP

Excel

Validation tools

Job description

Perrigo in New York, NY is seeking a Process Engineer to provide technical and scientific support for Rx, OTC, and cosmetic topical products, working with Regulatory Affairs, Quality, R&D, Operations and Legal to develop, transfer and validate manufacturing processes.

You will support scale-up, investigate deviations, implement CAPAs, and ensure product quality and regulatory compliance. This role offers opportunities for growth within a collaborative, inclusive culture.