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.

Supervisory Responsibilities

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• Recruits, interviews, hires, and trains new staff in accordance with company procedures.
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• Oversees daily workflow, assigns tasks, and manages resource planning.
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• Provides constructive and timely performance evaluations.
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• Handles discipline and termination of employee in accordance with company policy.
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• Ensures team compliance with training requirements, safety programs and GMP expectations

Duties and Responsibilities

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• Support data integrity, audit readiness, and lifecycle management of electronic laboratory systems and analytical equipment.
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• L eads instrument onboarding, installation, qualification, and c omputer system validation (CSV) acti vities for new or modified laboratory equipment and software systems.
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• Authors, reviews, and maintains validation documentation, ensuring alignment with GAMP and GxP expectations.
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• Perform s routine and non-routine troubleshooting of laboratory instruments to identify root causes, restore operation, and minimize downtime.
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• Coordinate and oversees instrument repairs, preventive maintenance, and service activities with internal teams and external vendors.
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• Support s calibration and metrology programs, including scheduling, documentation review, and management of out-of-tolerance events.
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• Owns or contributes to deviations, investigations, CAPAs, and change controls related to laboratory equipment and computerized systems.
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• Maintains and updates SOPs, work instructions, and related documentation to ensure compliance and operation consistency.
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• Participates in internal and external audits, providing documentation, subject-matter expertise, and corrective action support.
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• Manages vendor relationships, service contracts, and provides budgetary input for equipment lifecycle planning.

Required Skills and Abilities

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

Education and Experience

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

Physical Requirements

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• Prolonged periods of sitting or standing at a desk and working on a computer.
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• Prolonged periods of sitting or standing in laboratory environment.
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• Must be able to lift up to 3 5 pounds at times.
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• Motor skills required for basic laboratory operations.