Process Engineer

Pharmaron • Coventry, RI

4d • Onsite

About The Position

The Process Engineer will support technology transfer, process scale-up, commissioning, qualification, and validation (CQV), as well as commercial manufacturing activities within a large-scale pharmaceutical drug substance manufacturing facility. This role will play a key part in ensuring the safe, efficient, reliable, and compliant production of Active Pharmaceutical Ingredients (APIs), intermediates, and other pharmaceutical compounds. The Process Engineer will work cross-functionally with Process Chemistry, Manufacturing, Quality Assurance, Quality Control, Supply Chain, and Environmental Health and Safety (EHS) teams to bring processes from development through commercial manufacturing while supporting continuous improvement and operational excellence.

Requirements

• Bachelor of Science Degree in Chemical Engineering or closely related field
• 2+ years of work-related experience in manufacturing or engineering work associated with pharmaceutical ingredients, specialty or fine chemicals
• Working as project member within cross-functional teams
• Familiarity with cGMP's and FDA regulations
• Familiarity with OSHA Process Safety Management Standard

Responsibilities

• Define appropriate process scale and equipment selection for new processes within existing manufacturing facilities.
• Support technology transfer projects from development through manufacturing implementation.
• Generate and maintain GMP documentation, including batch records, testing protocols, SOPs, and related technical documentation.
• Provide appropriate training to Operations personnel on new and modified processes.
• Assist with assessment of process chemistry optimization and compilation and analysis of process safety data.
• Manage process safety concerns and support Process Safety Management (PSM) implementation using established site procedures, including thermal hazard assessments, relief design, and Process Hazard Analyses (PHAs).
• Provide technical support during production activities, troubleshooting issues and helping ensure the safe, compliant, and efficient execution of manufacturing processes.
• Provide on-call technical support as required during new process start-ups.
• Generate and own change controls, quality events, CAPAs, and other quality system activities supporting ongoing production.
• Design, specify, and install new equipment or equipment modifications ranging from small to moderate scope, depending on experience.
• Perform and support commissioning, qualification, and validation (CQV) activities in accordance with the site master plan.
• Participate in team safety meetings and complete engineering-related safety action items.
• Support the administration and maintenance of the site's engineering document repository, including AutoCAD Vault.
• Partner cross-functionally with Manufacturing, Quality, Process Chemistry, EHS, and other site teams to resolve technical issues and drive continuous improvement.

Benefits

• Comprehensive Medical, Dental & Vision Insurance with significant employer contributions
• 401(k) Retirement Plan with generous employer matching
• Generous Paid Time Off (PTO), Paid Sick Leave & Company Holidays to support work-life balance
• Employer-funded Health Savings Account (HSA) contributions (for eligible plans), plus Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life Insurance, AD&D, Short- and Long-Term Disability Insurance
• Employee Assistance Program (EAP), mental health resources, and wellness programs
• Family-friendly benefits, including fertility support and maternity resources
• Professional development and career growth opportunities within a leading global CRO/CDMO

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level