Validation Engineer

Vpicompounding; Centennial (CO); Sur place; USD 48 000 - 55 000; Plein temps

Avantages offerts par ce poste

Company-paid health, dental, andVision

401(k) plan with employer match

6 paid company holidays per year

32 hours of PAID floating holiday time

Paid Time Off (PTO) accrual

Tuition and certification reimburse

RTD EcoPass for public transportation

Career growth opportunities with hands

On-site training and advancement

Résumé du poste

VPI Compounding Pharmacy seeks a Validation Engineer to support pharmaceutical manufacturing operations in Centennial, CO. This full-time role emphasizes hands-on work, cGMP compliance, and developing and maintaining validation documentation throughout the lifecycle.

The ideal candidate will coordinate equipment and process qualifications, assist with cleanroom certifications, and liaise with vendors to ensure regulatory standards are met.

Qualifications

• Understanding of scientific and mathematical principles.
• Strong verbal and written communication skills.
• Ability to read and follow SOPs, cGMPs, and regulatory guidelines.

Responsabilités

• 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.

Connaissances

Scientific principles

Verbal and written communication

Regulatory guidelines interpretation

Formation

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

Outils

Microsoft Word

Microsoft Excel

Description du poste

Validation Engineer
Department: Engineering
Location: Centennial, CO
Employment Type: Full-Time
Compensation: $35–$40 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

VPI Compounding offers a competitive benefits package for eligible employees, including:

• Company-paid health, dental, and vision insurance
• 401(k) plan with employer match
• 6 paid company holidays per year
• 32 hours of PAID floating holiday time per year, separate from PTO
• Paid Time Off (PTO) accrual
• Tuition and certification reimbursement programs
• RTD EcoPass for public transportation
• Career growth opportunities with hands‑on training and advancement support

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.