Laboratory Instrumentation and Validation Specialist

Serán BioScience•Bend, OR

3d•Onsite

About The Position

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.

Requirements

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.

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.
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.