Validation Engineer

Multiple Levels and Openings
Alliance Biotech Solutions (ABS) is actively hiring multiple Validation Engineers to support a growing portfolio of projects across pharmaceutical and biotech clients in the RTP area.

The roles are focused on supporting commercial manufacturing operations and late-stage clinical/GMP environments, with responsibilities spanning a broad range of validation and qualification disciplines. We are seeking professionals with experience in areas including, but not limited to, equipment qualification (IQ/OQ/PQ), cleaning validation, process validation (PPQ), computerized systems validation (CSV), automation/controls validation (e.g., PLC/SCADA systems), commissioning and qualification (C&Q), and utilities validation (e.g., WFI, clean steam, HVAC).
Additional experience may include risk assessments (e.g., FMEA), deviation investigations, change control, data integrity initiatives, environmental monitoring support, and validation lifecycle management, along with validation gap assessments, remediation activities, and inspection readiness support. Candidates will play a key role in ensuring compliance with global regulatory requirements while driving efficient, high-quality execution across client engagements.
Key Responsibilities
Partner with project managers and client stakeholders to understand scope, priorities, and deliverables across multiple GMP-regulated projects
Support execution of validation and qualification activities across a range of systems and processes, including equipment, utilities, automation, and computerized systems
Develop, review, and execute validation lifecycle documentation, including protocols (e.g., IQ/OQ/PQ, CSV deliverables) and summary reports
Perform field execution activities, including commissioning support, qualification testing, and documentation of results in accordance with cGMP requirements
Support automation and computerized systems validation, including validation of PLC/SCADA-based systems and data integrity considerations
Contribute to risk assessments (e.g., FMEA), deviation investigations, change control, and CAPA activities
Provide lifecycle support for validated systems, including periodic review, requalification, and troubleshooting
Collaborate cross-functionally with Engineering, Manufacturing, Quality, and IT/Automation teams to ensure compliant and efficient project execution
Support inspection readiness efforts, including audit support and remediation activities as needed
Experience Desired
3–10+ years of experience supporting commissioning, qualification, and validation (CQV), CSV, or related activities in cGMP-regulated environments
Hands-on experience across one or more validation disciplines, such as equipment qualification, process validation (PPQ), cleaning validation, utilities validation, automation/controls validation, or computerized systems validation (CSV)
Experience working within commercial manufacturing or GMP clinical environments, preferably in pharmaceutical or biotechnology settings
Familiarity with validation of process equipment, utilities (e.g., WFI, clean steam, HVAC), automation systems (PLC/SCADA), and/or laboratory systems
Understanding of validation lifecycle principles, including documentation practices, data integrity, and regulatory compliance expectations
Exposure to validation gap assessments, remediation, or inspection readiness activities is a plus
Familiarity with validation tools and platforms (e.g., electronic validation systems such as Kneat or similar, data acquisition tools, or paperless validation solutions)
Skills and Abilities
Good technical problem-solving and troubleshooting skills
High attention to detail
Great interpersonal and organizational skills.
Ability to multi-task and take initiative to accomplish assigned tasks accurately while taking established deadlines into account
Willing and able to thrive in unusually fast paced and changing environments
Ability to change priorities in response to company demands while continuing to deliver results

Benefits
Industry competitive wage as a full-time employee
Flexible Paid Time Off
Bonus plans
Medical, Dental and Vision Insurance with low employee cost
Employer paid long term and short-term disability
401k plan with employer contributions
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