Senior Validation Engineer

PROMED MOLDED PRODUCTS INC•Plymouth, MN

68d•$94,374 - $130,236•Onsite

About The Position

The mission of the Senior Engineer, Validation is to ensure that our facility, equipment, utilities, and manufacturing processes consistently perform as intended and remain in a state of control that satisfies cGMP and regulatory expectations. This role owns the technical rigor behind qualification and validation activities that give our clients and regulators confidence in every batch we produce. The position requires deep technical expertise in process validation, strong document authorship and review skills, and the ability to lead validation activities across multiple concurrent client programs in a fast-paced CDMO environment. The Senior Validation Engineer supports ProMed’s mission and values by applying and reinforcing the company’s brand, philosophy, systems, policies, and procedures are consistently applied and upheld in all aspects of their work.

Requirements

Deep knowledge of cGMP requirements and FDA/EMA expectations for process validation.
Hands-on experience authoring and executing validation studies a regulated manufacturing environment.
Experience developing cleaning validation programs, including toxicological limit-setting and analytical sampling methods.
Strong statistical and data analysis skills to support validation acceptance criteria and continued process verification.
Ability to manage multiple concurrent validation projects across client programs with competing priorities.
Excellent technical writing and cross-functional communication skills.
Bachelor's degree in Engineering, Chemistry, Pharmaceutical Sciences, or related scientific discipline.
5+ years of experience in validation, equipment qualification, or process engineering within a pharmaceutical, biotechnology, or CDMO environment.
Demonstrated experience authoring and executing manufacturing process and/or cleaning validation studies.
Working knowledge of statistical tools used in validation and continued process verification.
Experience supporting regulatory inspections or client audits related to validation activities.

Responsibilities

Author and maintain site and project-level Validation Master Plans (VMPs) defining scope, strategy, and lifecycle approach for equipment, utilities, and process validation.
Develop risk-based validation strategies that align with regulatory expectations (FDA, EMA, ICH Q7/Q8/Q9/Q10) and client requirements.
Establish and maintain validation policies, SOPs, and templates to support consistent execution across programs.
Partner with Quality Assurance to ensure validation approaches are appropriately risk-assessed and documented.
Author and execute Performance Qualification (PQ) and Process Performance Qualification (PPQ) protocols for manufacturing processes transferring from development to commercial-scale production.
Develop and execute cleaning validation protocols, including selection of worst-case products, swab/rinse sampling plans, and acceptance criteria based on toxicological limits (e.g., PDE/ADE).
Collaborate with Process Development and Manufacturing to define critical process parameters (CPPs) and critical quality attributes (CQAs) supporting validation acceptance criteria.
Analyze validation data and author final summary reports with statistically sound conclusions supporting process and cleaning validation status.
Support continued process verification (CPV) programs to maintain the validated state throughout the product lifecycle.
Serve as validation subject matter expert (SME) for client-facing technical discussions, audits, and regulatory inspections.
Lead or support investigations into validation-related deviations, ensuring timely and technically sound root cause analysis and CAPA development.
Mentor junior validation engineers and provide technical guidance on protocol authorship, execution, and reporting.
Present validation strategies, progress, and results to client stakeholders and internal governance teams.