Equipment Validation Engineer

Alliancebiotechsolutions; Raleigh (NC); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Dental and Vision Insurance

Paid long-term and short-term disability

401K plan with employer contributions

Job summary

Alliance Biotech Solutions in Raleigh, North Carolina, is seeking a Validation Specialist to support equipment qualification activities in GMP-regulated environments. The ideal candidate will have 2+ years of experience with CQV activities and strong knowledge of GMP regulations. Responsibilities include executing validation protocols, investigating discrepancies, and collaborating with cross-functional teams. The position offers competitive wages and benefits including dental and vision insurance and a 401K plan.

Qualifications

• 2+ years experience in GMP-regulated environments for mid-level or 5+ years for senior.
• Experience with equipment qualification and single-use technologies preferred.
• Ability to interpret technical documentation including process flow diagrams.

Responsibilities

• Execute and support equipment qualification activities.
• Participate in qualification of lab instruments.
• Investigate deviations and perform root cause analysis.

Skills

Supporting CQV/validation activities

Understanding GMP regulations

Technical writing

Problem-solving capabilities

Communication skills

Job description

Requirements

• Execute and support equipment qualification activities including IQ/OQ/PQ protocol development, execution, and report generation
• Support validation efforts for single-use systems including single-use mixers (SUMs), process pumps, and filtration systems (SUTFF)
• Participate in the qualification of lab instruments such as cell viability analyzers (e.g., Vi-Cell BLU) including potential CSV/data integrity support
• Perform on‑floor validation execution including system walkdowns, functional testing, and coordination with operations
• Support system integration activities, ensuring equipment and instrumentation operate within defined parameters
• Assist with updates and modifications to existing systems, including parameter and instrumentation changes
• Investigate deviations, discrepancies, and non‑conformances; perform root cause analysis and support corrective actions
• Ensure timely closure of validation deliverables and associated documentation
• Collaborate with cross‑functional teams to align validation activities with project timelines and operational priorities
• Author and review validation protocols, reports, and technical documentation
• Support execution within electronic validation and quality systems (e.g., KNEAT, TrackWise, Veeva or similar)

Experience / Skills

• 2+ years (mid‑level) or 5+ years (senior) of experience supporting CQV/validation activities in GMP‑regulated environments
• Experience with equipment qualification (IQ/OQ/PQ) for manufacturing and/or lab systems
• Exposure to single‑use technologies and/or biopharmaceutical manufacturing environments preferred
• Experience with CSV and data integrity concepts is a plus
• Strong understanding of GMP regulations and global compliance standards
• Ability to interpret technical documentation including P&IDs, URS, and process flow diagrams
• Strong technical writing and documentation skills
• Demonstrated analytical and problem‑solving capabilities
• Ability to work independently and manage multiple priorities in a fast‑paced project environment
• Strong communication skills with the ability to collaborate cross‑functionally

Benefits & Compensation

• Competitive wage as a full‑time employee
• Dental and Vision Insurance with low employee cost
• Paid long‑term and short‑term disability
• 401K plan with employer contributions

About Alliance Biotech Solutions

Alliance Biotech Solutions (ABS) is a premier consulting firm specializing in biopharmaceutical engineering and validation services. As industry leaders in Commissioning, Qualification, and Validation (CQV), we provide crucial services to the biotech and pharmaceutical sectors while maintaining our philosophy that employees are our #1 priority. Our success is built on the foundation of empowering our team members' growth and development, recognizing that our employees are the cornerstone of our clients' success.