Validation Engineer

Overview

We are seeking a skilled Validation Engineer with strong hands‑on experience in pharmaceutical equipment qualification and validation, with particular emphasis on automated Parts Washer systems. The successful candidate will have a solid background in GMP‑regulated pharmaceutical or biopharmaceutical manufacturing and experience supporting equipment qualification, cleaning‑cycle development, and cleaning validation activities from protocol development through execution and final documentation.

Location: Colorado (local candidates strongly preferred) | Industry: Pharmaceutical / Biopharmaceutical Manufacturing | Job type: Contract

Key Responsibilities

• Lead and support qualification and validation activities for automated Parts Washer systems used in GMP manufacturing environments.
• Prepare, review, execute, and finalize IQ, OQ, and PQ protocols and reports.
• Provide validation support during FAT, SAT, commissioning, startup, and equipment qualification activities.
• Review and assess technical documentation, including URS, FS, DS, P‑IDs, equipment specifications, and vendor documentation.
• Support the development, optimization, and qualification of Parts Washer cleaning cycles.
• Assess and document critical cleaning‑cycle parameters, including:
  • Wash and rinse temperatures
  • Cycle duration
  • Detergent or cleaning‑agent concentration
  • Spray pressure and coverage
  • Equipment loading configurations
  • Drying conditions and parameters
• Perform or support riboflavin testing and spray‑pattern/coverage studies.
• Support cleaning validation activities, including visual inspection, swab and rinse sampling, TOC, conductivity, and residue analysis as required.
• Assist in determining worst‑case equipment loads, soils, and cleaning conditions and establish appropriate acceptance criteria.
• Investigate and resolve deviations, discrepancies, change controls, and CAPAs related to validation and qualification activities.
• Collaborate closely with QA, Engineering, Manufacturing, QC, Operations, and equipment vendors.
• Ensure validation work is performed in accordance with cGMP requirements, FDA expectations, and site‑specific procedures.
• Generate and maintain accurate, complete, and audit‑ready validation documentation.

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, or a related technical discipline.
• Minimum 5 years of experience in pharmaceutical/biopharmaceutical validation, CQV, or equipment qualification.
• Hands‑on Parts Washer qualification or validation experience (critical requirement).
• Proven experience with IQ/OQ/PQ, FAT/SAT, commissioning, and equipment qualification.
• Strong understanding of GMP/cGMP pharmaceutical manufacturing environments.
• Practical knowledge of cleaning validation and cleaning‑cycle qualification.
• Experience preparing and executing validation protocols and managing associated deviations, change controls, and CAPAs.
• Ability to work independently and effectively within a GMP manufacturing/site environment.
• Must be local to Colorado or willing and able to work fully onsite in Colorado.

Preferred Background

• Experience in pharmaceutical manufacturing equipment validation.
• Specific experience with automated Parts Washers.
• Background in cleaning validation, CQV, or GMP equipment qualification.