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- 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
Duties and Responsibilities- 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.
- Coordinate 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.
Required Skills and Abilities- 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.
Education and Experience- 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.
Physical Requirements- 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.
