Validation Engineer

Validation Engineer

Department: Engineering

Location: Centennial, CO

Employment Type: Full-Time

Compensation: $35-$38 per hour DOE

We're looking for a driven and detail-oriented Validation Engineer to support pharmaceutical manufacturing operations and ensure equipment and processes meet the highest industry and regulatory standards. The ideal candidate will be hands-on and solutions-focused, with a strong understanding of cGMPs and validation protocols. This role requires a professional who can work across departments, contribute to cleanroom and equipment certifications, and provide technical support throughout the validation lifecycle. If you have a passion for precision and quality in a regulated environment, we'd love to meet you.

Key Responsibilities

Validation & Documentation

Develop, write, and maintain validation protocols, reports, and SOPs in compliance with FDA, USP, and cGMP requirements

Coordinate and execute equipment and process qualifications

Maintain full documentation throughout the validation lifecycle

Support cleanroom certification and recertification every six months Equipment & Process Support

Assist with sourcing and validating new equipment

Monitor and resolve equipment and production issues

Evaluate current equipment and procedures for compliance and efficiency

Communicate with vendors for equipment setup, troubleshooting, and repair Facility Support & Compliance

Ensure all activities align with cGMPs, safety regulations, and internal SOPs

Support facility maintenance and participate in internal/external audits

Perform duties of a Manufacturing Technician as needed, including equipment operation, batch record documentation, and adherence to all regulatory requirements Qualifications

Required:

Bachelor's degree in Engineering (Chemical, Mechanical, Manufacturing, Electrical, or Software)

Understanding of scientific and mathematical principles

Strong verbal and written communication skills

Proficiency in Microsoft Word and Excel

Ability to read and follow SOPs, cGMPs, and regulatory guidelines Preferred:

2-4 years of validation experience in pharmaceutical or life sciences industry

Experience with technical writing and document creation

Mechanical aptitude and hands-on troubleshooting experience Physical Demands

Must be able to work on-site in a cleanroom environment

May require standing for extended periods and moving equipment during validation procedures Benefits

Company-paid health, dental, and vision insurance

401(k) plan with employer match

Paid holidays and Floating holidays

Tuition Reimbursement

RTD EcoPass for public transportation

Opportunities for professional growth and development

Equal Opportunity Employer

VPI Compounding Pharmacy is an Equal Employment Opportunity (EEO) employer. We are committed to providing equal opportunity for all qualified individuals employed by or seeking employment with VPI, regardless of race, color, creed, religion, sex, sexual preference, national origin, age, marital status, veteran status, or non-job-related disabilities. This policy extends to all areas of employment, including recruitment, job assignment, promotion, and other terms of employment.