Process Engineer

Systems Ally; Swiftwater (Monroe County); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a highly skilled Senior Process and Validation Engineer to optimize biologic drug substance manufacturing processes. This role involves deep technical expertise in process and cleaning validation, ensuring compliance with industry standards, and contributing to continuous improvement initiatives. You will lead cross-functional teams, develop validation protocols, and interface with external partners to support tech transfers. If you are passionate about advancing manufacturing processes and thrive in a collaborative environment, this opportunity is perfect for you.

Qualifications

• 3-7 years in biologics or pharma manufacturing.
• Expertise in downstream unit operations and cleaning validation.

Responsibilities

• Serve as SME for process development and cleaning validation.
• Develop and execute validation protocols in a cGMP environment.

Skills

Process Analysis

Troubleshooting

Six Sigma Practices

Cleaning Validation

Technical Writing

Data Analytics

Education

Bachelor’s or Master’s in Chemical/Biochemical Engineering

Tools

PI Historian

LIMS

MES

DCS

E-Doc/GEODE+

Job description

No C2C / Only W2

Role Description

Looking for Process Engineer and Validation Engineer, located in Swiftwater, PA, for contract roles. The Process Engineer and Validation Engineer will be responsible . The role will involve day-to-day tasks such as process analysis, troubleshooting, and implementation of Six Sigma practices, among others.

We are seeking a highly skilled Senior Process and Validation Engineer to serve as a key contributor in the strategy development, execution, and validation of biologic drug substance, small molecules and manufacturing processes. This role combines deep technical expertise in process and cleaning validation, for optimizing manufacturing processes, ensuring compliance with industry standards, working on validation processes, performing quality control and assurance, and contributing to continuous improvement initiatives, strong project leadership, and hands-on experience supporting commercial manufacturing operations across internal and external sites.

Key Responsibilities

• Serve as Subject Matter Expert (SME) for process development, scale-up, cleaning validation, and investigations.
• Develop and execute process and cleaning validation protocols, including bracketing, worst-case analysis, and swab/rinse sampling strategies.
• Lead design space/DoE studies and apply engineering fundamentals (mass/heat transfer, mixing, modeling) to define and optimize process parameters.
• Author, review, and approve validation documentation including protocols, reports, SOPs, and technical memos in a cGMP environment.
• Collaborate cross-functionally with Quality, Manufacturing, and MSAT to support deviations, CAPAs, change controls, and inspection readiness.
• Provide technical leadership and training to teams and stakeholders on validation strategies, equipment capabilities, and process improvements.
• Interface with CMOs to support tech transfer, routine monitoring, person-in-plant oversight, and continuous improvement initiatives.
• Support equipment and transport IOQ/PPQ qualifications for packaging, downstream purification, and liquid formulation processes.
• Contribute to internal systems improvements and maintain compliance with FDA, EMA, ASTM, USP, and ICH guidelines.

Preferred Experience and Skills

• 3-7 years in biologics or pharma manufacturing (cell culture, downstream purification, liquid formulation, or adjuvants).
• Expertise in downstream unit operations: UF/DF, chromatography, filtration, viral clearance, and extractables/leachables.
• Strong experience in cleaning validation, including dirty/clean hold times, acceptance criteria, and data review.
• Proficiency in data analytics and use of systems like PI Historian, LIMS, MES, DCS, and E-Doc/GEODE+.
• Hands-on knowledge of Good Manufacturing Practices (GMPs), regulatory expectations, and formal root cause analysis.
• Strong technical writing and communication skills; ability to interact with senior leadership and external partners.
• Experience in equipment start-up, qualification, packaging validation, and global tech transfers.
• Comfortable working independently and leading cross-functional project teams in a matrixed environment.

Education Requirements

• Bachelor’s or Master’s degree in Chemical/Biochemical Engineering, Pharmaceutical Sciences, or related field.
• Strong working knowledge of Cleaning and Process Validation, QbD, Design Control, and process control strategies.