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Quotient Sciences · 7 hours ago

Process Engineer

Philadelphia, PA

Full-time

Onsite

Senior Level

5+ years exp

Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. The Process Validation Engineer will ensure successful product development, technical transfer, and validation activities across manufacturing operations, acting as a subject matter expert in process development and validation.

Clinical TrialsCommercialConsultingHealth CareManufacturingMedicalPharmaceutical

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

Qualification

Process ValidationTechnical TransferLean ManufacturingOral Solid DosageSix SigmaStatistical AnalysisMicrosoft Office SuiteMultitaskingLeadershipTime ManagementCommunication Skills

Required

Bachelor's degree in Engineering (Industrial, Mechanical, Electrical, Chemical), Pharmaceutical Sciences or related field required

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

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

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