Senior Validation Engineer

Beacon Hill Staffing Group, LLC; Indianapolis (IN); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Paid time off and leave programs

Flexible work arrangements

Job summary

Beacon Hill Staffing Group, LLC is seeking a Senior Validation Engineer to lead validation, qualification, and calibration activities across manufacturing and laboratory environments. The role ensures equipment, utilities, and computer systems meet regulatory and quality standards.

Ideal candidates will drive validation strategies, author IQ/OQ/PQ protocols, and oversee calibration programs while supporting regulatory inspections and continuous improvement initiatives.

Qualifications

• Bachelor's degree in a technical field is required.
• 5+ years in validation, qualification, calibration, or commissioning in GMP settings.
• Strong understanding of cGMP, FDA requirements, and Data Integrity principles.
• Experience authoring and executing IQ/OQ/PQ protocols and validation reports.
• Experience supporting equipment qualification, utilities validation, and manufacturing systems.

Responsibilities

• Lead validation activities from project planning through execution and final approval.
• Develop and maintain Validation Master Plans (VMPs) and validation strategies.
• Author, review, and execute IQ, OQ, and PQ protocols and tests.
• Support capital expansion, facility upgrades, and process improvements.
• Oversee calibration documentation and traceability requirements.
• Ensure compliance with regulatory and quality standards across systems.

Skills

Technical writing

Project management

Regulatory knowledge

Quality systems

Education

Bachelor's degree in Engineering, Life Sciences, Chemistry, or related technical discipline

Tools

Kneat

ValGenesis

MasterControl

Veeva

TrackWise

Job description

Beacon Hill was founded to set a new standard in search, career placement and flexible staffing.

Position Overview

We are seeking an experienced Senior Validation Engineer to lead validation, qualification, and calibration activities supporting capital projects, manufacturing operations, laboratory systems, and regulated processes. This role will serve as a key technical resource responsible for ensuring equipment, utilities, computerized systems, and manufacturing processes meet regulatory, quality, and operational requirements.

Key Responsibilities

Validation Strategy & Project Execution

• Lead validation activities from project planning through execution and final approval.
• Develop and maintain Validation Master Plans (VMPs), validation strategies, qualification plans, and validation lifecycle documentation.
• Author, review, and execute IQ, OQ, and PQ protocols, test scripts, validation reports, and traceability matrices.
• Support capital expansion, facility upgrades, equipment installations, and process improvement initiatives.

Equipment Qualification & Calibration

• Lead qualification and calibration activities for manufacturing equipment, laboratory instruments, utilities, and facility systems.
• Ensure calibration programs maintain compliance with internal procedures and industry standards.
• Oversee calibration documentation, traceability requirements, and record management.
• Support commissioning and qualification efforts for new equipment and systems.

Computer System Validation (CSV)

• Execute and support validation efforts for computerized systems including: SCADADCSMESLIMSData HistoriansLaboratory Software Systems.
• Ensure compliance with GAMP 5, 21 CFR Part 11, and Data Integrity requirements.

Risk Assessment & Change Management

• Conduct risk assessments utilizing FMEA, impact assessments, and criticality analyses.
• Evaluate changes to equipment, processes, facilities, and software systems to determine validation requirements.
• Apply risk-based validation principles in accordance with ASTM E2500 and ICH guidelines.

Compliance & Regulatory Support

• Ensure validation and qualification activities comply with: FDA regulationscGMP requirements21 CFR Parts 210, 211, and Part 11ASTM E2500ICH Q7, Q8, Q9, and Q10GAMP 5.
• Support regulatory inspections, customer audits, and internal quality audits.
• Prepare validation documentation packages and provide technical responses during inspections.

Continuous Improvement

• Identify and implement improvements to validation and calibration programs.
• Drive standardization of validation processes, templates, and best practices.
• Support initiatives focused on efficiency, compliance, and operational excellence.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry, or a related technical discipline.
• 5+ years of experience in validation, qualification, calibration, or commissioning within pharmaceutical, biotechnology, medical device, or other GMP-regulated environments.
• Strong understanding of: cGMP regulationsFDA requirementsASTM E2500ICH guidelinesGAMP 521 CFR Part 11Data Integrity principles.
• Experience authoring and executing IQ/OQ/PQ protocols and validation reports.
• Experience supporting equipment qualification, utilities validation, and manufacturing systems.
• Excellent technical writing, communication, and project management skills.

Preferred Qualifications

• Experience supporting large-scale CAPEX projects.
• Experience with aseptic manufacturing, sterile processing, biologics, or advanced therapy manufacturing.
• Experience with process validation, cleaning validation, and CSV programs.
• Familiarity with validation management platforms such as Kneat or ValGenesis.
• Experience with electronic quality systems such as MasterControl, Veeva, or TrackWise.
• Knowledge of calibration standards, uncertainty analysis, and metrology principles.
• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or other relevant certifications.
• Proven history of supporting successful FDA and regulatory inspections.

Beacon Hill is an equal opportunity employer and individuals with disabilities and/or protected veterans are encouraged to apply.

California residents: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

Company Profile

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement. Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs. Learn more about Beacon Hill and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.bhsg.com.

Benefits Information

Beacon Hill offers a robust benefit package including, but not limited to, medical, dental, vision, and federal and state leave programs as required by applicable agency regulations to those that meet eligibility. Upon successfully being hired, details will be provided related to our benefit offerings.

We look forward to working with you!Beacon Hill. Employing the Future