Laboratory Instrumentation and Validation Specialist

Laboratory Instrumentation And Validation Specialist

Serán 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.

• Recruits, interviews, hires, and trains new staff in accordance with company procedures.
• Oversees daily workflow, assigns tasks, and manages resource planning.
• Provides constructive and timely performance evaluations.
• Handles discipline and termination of employee in accordance with company policy.
• Ensures 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.
• Leads instrument onboarding, installation, qualification, and computer system validation (CSV) activities for new or modified laboratory equipment and software systems.
• Authors, reviews, and maintains validation documentation, ensuring alignment with GAMP and GxP expectations.
• Performs routine and non-routine troubleshooting of laboratory instruments to identify root causes, restore operation, and minimize downtime.
• Coordinates and oversees instrument repairs, preventive maintenance, and service activities with internal teams and external vendors.
• Supports calibration and metrology programs, including scheduling, documentation review, and management of out-of-tolerance events.
• Owns or contributes to deviations, investigations, CAPAs, and change controls related to laboratory equipment and computerized systems.
• Maintains and updates SOPs, work instructions, and related documentation to ensure compliance and operation consistency.
• Participates in internal and external audits, providing documentation, subject-matter expertise, and corrective action support.
• Manages vendor relationships, service contracts, and provides 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.