Senior Validation Engineer

Socket.dev; Plymouth (MN); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

401k with company match

Profit Sharing Program

Medical Insurance

Health Savings Account

Dental Insurance

Vision Insurance

Life Insurance

Paid Family Medical Leave

Hospital Indemnity

Critical Illness

Accident

Identity Theft Protection

Pet Insurance

Job summary

ProMed in Minnesota seeks a Senior Validation Engineer to ensure our facility, equipment, and processes stay in control and compliant with cGMP and regulatory expectations. You will lead validation strategies, PQ/PPQ execution, and cross-functional collaboration with QA, Process Development, and Manufacturing across multiple client programs.

The role demands strong technical writing, data analysis, and the ability to mentor junior engineers while guiding audits and inspections.

Qualifications

• 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 Validation Master Plans 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 PQ and 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 CPPs and 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 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.

Skills

cGMP knowledge

Validation studies

Cleaning validation

Statistical analysis

Project management

Technical writing

Cross-functional communication

Education

Bachelor's degree in Engineering, Chemistry, Pharmaceutical Sciences, or related scientific discipline

Tools

Statistical tools

Job description

As a ProMed employee, you will contribute to the manufacture of products that have a significant impact on people’s lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best.

ProMed was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world.

Working as one to help many.

WHY THIS ROLE MATTERS

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.

WHAT YOU’LL ACHIEVE

While the ways that you fulfill these responsibilities will likely evolve, your core responsibilities are:

Validation Strategy & Master Planning

On average, this will represent about 30% of your time. In this aspect of your position, we will expect you to:

• 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.

Process & Cleaning Validation (PQ/PPQ)

On average, this will represent about 45% of your time. In this aspect of your position, we will expect you to:

• 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.

Cross-Functional Leadership & Client Support

On average, this will represent about 25% of your time. In this aspect of your position, we will expect you to:

• 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.

Necessary Expertise and Skills:

• 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.

MINIMUM REQUIREMENTS

Minimum Qualifications For The Role:

• 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.

Physical, Sensory, Cognitive & Neurological Demands:

• Requires the ability to safely perform the physical movements necessary to carry out the essential functions of the role, including sitting, standing, walking, bending, reaching, lifting, pushing, pulling, and repetitive movements throughout the workday.
• Occasional lifting up to 25–35 lbs
• Donning and working in PPE, including cleanroom gowning
• Manual dexterity for instruments and sampling tools
• Visual acuity for reading technical documents and instrumentation
• Ability to distinguish color-coded labels and safety markings
• Hearing sufficient to detect alarms and verbal instructions
• Tactile sensitivity for equipment and sample handling
• Sustained focus and attention to detail
• Strong analytical and problem-solving skills
• Ability to manage multiple concurrent priorities
• Sound judgment under regulatory scrutiny
• Clear verbal and written communication
• Alertness in a safety-sensitive environment
• Ability to manage stress during audits and investigations
• Adequate coordination/reflexes for equipment operation
• Adaptability to shifting priorities

ProMed offers a generous benefits package including:

• 401k with company match
• Profit Sharing Program
• Medical Insurance
• Health Savings Account/Flexible Spending Account
• Dental Insurance
• Vision Insurance
• Life Insurance
• Paid Family Medical Leave and Long-Term Disability Insurance
• Hospital Indemnity, Critical Illness, Accident, and Identity Theft Protection
• Pet Insurance

ProMed does not discriminate in employment opportunities or practices on the basis of race, color, creed, religion, national origin, ancestry, age, sex, marital status, order of protection, disability, military status, sexual orientation, gender identity, pregnancy, public assistance, family status, unfavorable discharge from military service, genetic information or other segmenting factor protected by law, or local human rights commission activity.