Strategic Equipment & Process Validation Engineer

Katalyst CRO; Richmond (VA); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO in Virginia seeks a Validation Engineer to support facility-wide validation review and remediation within a regulated manufacturing environment. The consultant will perform periodic reviews of manufacturing equipment, processes, and QC laboratory systems to ensure continued validated state.

You will draft and revise validation plans, risk assessments, protocols, and final reports, and execute qualification activities as required.

Qualifications

• 2–3 years of equipment qualification or process validation experience.
• Experience in pharmaceutical/biotechnology/medical device or similarly regulated manufacturing.
• Hands-on experience with IQ, OQ, PQ and validation lifecycle documentation.
• Strong protocol-writing and technical-writing skills.
• Ability to interpret SOPs, specifications, risk documents, validation protocols, and engineering records.
• Onsite work in Virginia five days per week.
• Working knowledge of cGMP requirements and validation practices.

Responsibilities

• Conduct periodic validation reviews for manufacturing equipment, processes, utilities, and QC lab systems.
• Review legacy qualification and process validation documentation for completeness, accuracy.
• Compare existing validation packages against current SOPs, regulatory expectations, and system risk profiles.
• Perform gap assessments and risk assessments to identify deficiencies in the current validated state.
• Develop remediation plans and complete assigned corrective validation activities.
• Draft, revise, and execute IQ, OQ, PQ, process validation, and related qualification protocols as applicable.
• Prepare validation plans, risk assessments, protocols, summary reports, and supporting technical documentation.
• Review executed protocols for completeness, accuracy, data integrity, deviations, and required follow-up.
• Support deviation resolution, change control, management-of-change activities, and documentation updates.
• Work with Engineering, Manufacturing, Quality, Automation, and laboratory personnel to collect technical information and resolve documentation gaps.
• Maintain organized, inspection-ready documentation within an electronic quality management system.
• Manage assigned reviews independently and communicate project status, risks, and obstacles to site leadership.
• Complete approximately one comprehensive periodic review or assigned system area per month, depending on complexity.

Skills

Technical writing

Documentation review

Protocol writing

Attention to detail

cGMP knowledge

Collaboration

Education

Bachelor's degree in Engineering or related technical discipline

Tools

MasterControl

TrackWise

PLM platforms

Job description

Katalyst CRO in Virginia seeks a Validation Engineer to support facility-wide validation review and remediation within a regulated manufacturing environment. The consultant will perform periodic reviews of manufacturing equipment, processes, and QC laboratory systems to ensure continued validated state.

You will draft and revise validation plans, risk assessments, protocols, and final reports, and execute qualification activities as required.