Process Engineer

Quotient Sciences : Molecule to Cure. Fast.We accelerate drug development by integrating formulation development, clinical testing, data sciences, and manufacturing into one seamless process. Our proprietary platform, Translational Pharmaceutics®, shortens timelines by 9–12 months on average. Arcinova, our specialist arm in Reading and Alnwick, UK, delivers end-to-end drug substance and early drug product services, including bioanalysis and radiolabeling—streamlining early development from candidate selection to proof of concept. Why join us? Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact—fast. The Role We are seeking a Process Validation Engineer to join our dynamic team at our Chelsea Parkway site. This role is pivotal in ensuring successful product development, technical transfer, and validation activities across manufacturing operations. You will act as a subject matter expert (SME) in process development and validation, supporting continuous improvement and compliance with regulatory standards. Main Tasks and Responsibilities Develop and own the master process validation plan; act as SME for process development. Collaborate with Product Development teams to ensure successful technical transfer to manufacturing. Coordinate and execute validation activities including protocols, MBRs, reports, change controls, deviations, and CAPAs. Author Product Quality Review Reports and Continued Process Validation Reports. Maintain compliance with GMP, federal and state regulations, and internal quality standards. Lead and support process improvement initiatives using lean manufacturing tools. Provide engineering support for equipment and manufacturing processes. Manage technical documentation including SOPs, standards, and drawings. Develop and update SOPs and templates for the Engineering team. Maintain up-to-date knowledge of pharmaceutical regulations and interpretations. Represent validation on site project teams and cross-functional initiatives. Develop and execute cleaning validation plans and process development batches. Lead risk assessments for process and cleaning validation. Qualifications and Experience Bachelor’s degree in Engineering (Industrial, Mechanical, Electrical, Chemical), Pharmaceutical Sciences or related field required. Master’s degree preferred. Minimum 5 years’ experience in product development, validation, and engineering within a regulated industry. Experience in Oral Solid Dosage (OSD) manufacturing is essential. Strong understanding of technology transfer, scale-up, and engineering principles. Lean, Six Sigma, and statistical analysis experience preferred. Skills and Abilities Advanced proficiency in Microsoft Office Suite including Project, Excel, Visio, and Minitab. Strong mathematical and troubleshooting skills, especially in mechanical / electrical systems and OSD manufacturing. Demonstrated leadership, time management, and multitasking abilities. Excellent oral communication and presentation skills. Ability to work in hazardous environments and adhere to strict safety protocols. Physical Demands Sit at a workstation 20% of the time; walk or stand in manufacturing areas 80%. Lift up to 49.9 lbs; team lift for 50–99.9 lbs; operate pallet jacks and PIT lifts. Wear PPE including safety glasses, Tyvek suits, and respirators in GMP environments. Operate office machinery and communicate effectively in written and verbal formats. Application Requirements When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined. Our Commitment to Diversity, Equity and Inclusion Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today. Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and / or local laws. This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.