Laboratory Instrumentation and Validation Specialist

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A1n is seeking a Laboratory Instrumentation and Validation Specialist. This person will be responsible for onboarding, maintaining, troubleshooting, repairing, and validating laboratory instruments and associated computerized systems within a regulated GMP environment. This role leads and develops a small technical team, ensuring effective task execution, clear communication, and timely reporting to project stakeholders. The position also provides hands‑on support for instrument troubleshooting, repair coordination, and computerized system validation activities to maintain reliable, compliant laboratory operations.

• Recruit, interview, hire, and train new staff in accordance with company procedures.
• Oversee daily workflow, assign tasks, and manage resource planning.
• Provide constructive and timely performance evaluations.
• Handle discipline and termination of employee in accordance with company policy.
• Ensure team compliance with training requirements, safety programs and GMP expectations.

• Support data integrity, audit readiness, and lifecycle management of electronic laboratory systems and analytical equipment.
• Lead instrument onboarding, installation, qualification, and computer system validation (CSV) activities for new or modified laboratory equipment and software systems.
• Author, review, and maintain validation documentation, ensuring alignment with GAMP and GxP expectations.
• Perform routine and non-routine troubleshooting of laboratory instruments to identify root causes, restore operation, and minimize downtime.
• Coordinate and oversee instrument repairs, preventive maintenance, and service activities with internal teams and external vendors.
• Support calibration and metrology programs, including scheduling, documentation review, and management of out-of-tolerance events.
• Own or contribute to deviations, investigations, CAPAs, and change controls related to laboratory equipment and computerized systems.
• Maintain and update SOPs, work instructions, and related documentation to ensure compliance and operational consistency.
• Participate in internal and external audits, providing documentation, subject-matter expertise, and corrective action support.
• Manage vendor relationships, service contracts, and provide budgetary input for equipment lifecycle planning.

• Experience supporting laboratory instruments in a QC or regulated laboratory environment.
• Familiarity with CSV, instrument qualification, and GMP documentation expectations.
• Hands‑on experience with HPLC, dissolution, balances, FTIR, or similar analytical instruments.
• Comprehensive knowledge of quality systems, cGMP, regulatory expectations across drug development through commercialization.
• Strong understanding of FDA, EU, Canadian, and ICH regulatory guidelines.
• Ability to maintain current knowledge of new technologies and potential applications.
• Excellent verbal and written communication skills.
• Strong interpersonal skills with the ability to collaborate cross‑functionally.
• Excellent organizational skills, attention to detail, and time management capabilities.
• Strong analytical and problem‑solving skills with demonstrated integrity in testing and reporting.
• Effective supervisory and leadership skills, including delegation and workload management.
• Ability to function well in a high‑paced and at times stressful environment.
• Proficiency with Microsoft Office Suite or related software.

• Bachelor’s degree in chemistry, engineering, or a related scientific field.
• Thorough knowledge of cGMP’s and familiarity with 21 CFR Part 11.
• Minimum of 1-2 years of experience in a lead or supervisory position.
• Minimum of 3-5 years of hands‑on experience with analytical instrumentation.

• Prolonged periods of sitting or standing at a desk and working on a computer.
• Prolonged periods of sitting or standing in laboratory environment.
• Must be able to lift up to 35 pounds at times.
• Motor skills required for basic laboratory operations.