Equipment and Process Validation Engineer

Job Description:

• The Validation Engineer will support a facility-wide validation review and remediation initiative within a regulated manufacturing environment.
• The consultant will perform periodic reviews of manufacturing equipment, processes, and selected QC laboratory systems to confirm that each system remains in a compliant and validated state.
• Responsibilities will include reviewing legacy validation packages, comparing existing documentation against current procedures and risk requirements, conducting gap and risk assessments, identifying deficiencies, and recommending or completing required remediation activities.
• The consultant will draft and revise validation plans, protocols, risk assessments, qualification documents, and final reports; execute qualification or validation protocols when required; document discrepancies; and ensure identified gaps are tracked through closure.
• The role will primarily involve detailed documentation review and technical writing, with additional responsibility for protocol execution, report preparation, change documentation, and collaboration with Engineering, Manufacturing, Quality, and laboratory personnel.

• Conduct periodic validation reviews for manufacturing equipment, processes, utilities, and selected QC laboratory systems.
• Review legacy equipment qualification and process validation documentation for completeness, accuracy, and continued compliance.
• 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.

• At least two to three years of equipment qualification, process validation, or manufacturing validation experience; three to five years is strongly preferred.
• Experience working in a pharmaceutical, biotechnology, medical device, or similarly regulated manufacturing environment.
• Hands-on experience with equipment qualification and process validation, including IQ, OQ, PQ, and validation lifecycle documentation.
• Demonstrated experience performing periodic reviews, validation assessments, gap assessments, or risk assessments.
• Experience reviewing legacy validation documentation and determining whether equipment or processes remain in a compliant validated state.
• Strong protocol-writing, technical-writing, document-review, and report-writing skills.
• Ability to interpret SOPs, specifications, risk documents, validation protocols, engineering records, and executed test results.
• Strong attention to detail and the ability to identify inconsistencies, missing information, compliance gaps, and documentation deficiencies.
• Working knowledge of cGMP requirements and validation practices within regulated manufacturing.
• Ability to work onsite five days per week in Virginia.
• Ability to manage assigned work independently while collaborating with cross-functional site personnel.

• Experience with regulated liquid processing, liquid handling, filling systems, or controlled filling operations.
• Pharmaceutical aseptic filling or IVDR medical-device manufacturing experience.
• Experience qualifying manufacturing equipment such as filling equipment, process skids, automated equipment, or related production systems.
• Familiarity with QC laboratory instrumentation qualification or periodic review.
• Experience with Master Control is preferred; experience with Track Wise, PLM platforms, or another electronic QMS is also acceptable.
• Experience…