Senior Engineer, Process Validation

About the role

The Senior Engineer, Process Validation is responsible for leading and supporting internal and external validation projects that enable the commercialization of vital new life-saving medicines. This position reports to the Process Validation Manager and is part of the Technical Operations Department located in Fargo, ND and will be fully remote.

Responsibilities

• Design, execute, and summarize deliverables across the three stages of process validation supporting process characterization and qualification spanning critical starting materials, drug substance, and drug product, product classifications aligned with FDA guidance, EU GMP Annex 15, and lifecycle approach.
• Lead the planning, execution, and lifecycle management of 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, labelling, packaging and shipping.
• Drive risk-based approaches using tools such as pFMEA, risk ranking, and criticality assessments and apply statistical tools to evaluate process performance, including but not limited to process capability, trend analysis and control charts and DOE) interpretation.
• Serve as a technical SME for process validation with external clients, across internal teams such as MSAT, manufacturing, QC, QA and RA, and during client audits and regulatory inspections, kaizens and workshop events.
• Mentor junior validation associates in Process Validation, cGMP regulations, and principles of Quality by Design.

Requirements

• Bachelor or master degree in engineering and 5+ years of experience
• Prior experience in leading process development, engineering, and deliverables across all three stages of process validation in biologics/small and large molecules manufacturing
• Train using statistical analysis, risk assessment, and process improvement tools required
• Knowledge of global regulatory requirements and cGMP regulations for pharmaceutical manufacturing operations and validation procedures and practices
• Proficiency in technical writing with deviation investigations, root cause analysis, and risk assessments

Travel, Motor Vehicle Record & Physical/Environment Requirements

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

Qualifications

• Knowledge of sterile fill-finish process validation, including sterile filtration, aseptic process simulation, sterile filling, visual inspection, container closure integrity testing, filter validation, labelling, packaging and shipping
• Experience with risk-based approaches using tools such as pFMEA, risk ranking, and criticality assessments
• Statistical tools for evaluating process performance, including process capability, trend analysis and control charts and DOE) interpretation
• Technical writing skills with experience in deviation investigations, root cause analysis, and risk assessments
• Experience with cGMP regulations and principles of Quality by Design

Skills

• Strong knowledge of global regulatory requirements and cGMP regulations for pharmaceutical manufacturing operations and validation procedures and practices
• Experience with statistical analysis, risk assessment, and process improvement tools
• Proven ability to lead and mentor junior validation associates
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team

Benefits

Aldevron offers a comprehensive package of benefits including paid time off, medical/dental/vision insurance, and a 401(k) plan to eligible employees. The annual salary range for this role is $100,000 to $130,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.