Senior Engineer, Process Validation

This Senior Engineer, Process Validation will support internal and external validation projects that enable the commercialization of vital new life‑saving medicines by leading and executing process validation across the entire product lifecycle.

Key Responsibilities

• Design, execute, and summarize deliverables across the three stages of process validation supporting process characterization and qualification for critical starting materials, drug substance, and drug product.
• Lead sterile fill‑finish process validation strategies and qualification programs for aseptic manufacturing processes, including sterile filtration, aseptic process simulation, sterile filling, visual inspection, container closure integrity testing, filter validation, labeling, packaging and shipping.
• Apply risk‑based approaches with tools such as pFMEA, risk ranking, criticality assessments, statistical process performance evaluation, trend analysis, control charts and DOE interpretation.
• Serve as a technical SME for process validation with external clients, a range of internal teams (MSAT, manufacturing, QC, QA and RA), and during client audits, regulatory inspections, kaizens and workshop events.
• Mentor junior validation associates in Process Validation, cGMP regulations and principles of Quality by Design.

Essential Requirements

• Bachelor’s or master’s degree in engineering and at least 5 years of experience.
• Prior experience leading process development and validation across all three stages of process validation in biologics, small molecule, and large molecule manufacturing using statistical analysis, risk assessments and process improvement tools.
• Knowledge of global regulatory requirements and cGMP regulations for pharmaceutical manufacturing operations and validation procedures.
• Proficiency in technical writing, deviation investigations, root cause analysis and risk assessments.

Additional Qualifications

• Packaging and shipping validation of final product container closure configurations.
• Client‑facing roles and prior experience in a CDMO environment.

Travel, Motor Vehicle Record & Physical/Environment Requirements

• Ability to travel 15% to site for validation project executions, routine inspections, audits and client visits.

Benefits & Compensation

Annual salary range: $100,000 to $130,000. Eligible for bonus/incentive pay.

Comprehensive benefits include paid time off, medical, dental and vision insurance, and a 401(k) plan. Remote work arrangement is available for this eligible role.

Legal & EEO Statements

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We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed for the job application or interview process, to perform essential job functions and/or to receive other benefits and privileges of employment, contact 1‑202‑419‑7762 or