Company
Pharma
LaboratoryInstrumentationandValidationSpecialist
Neural analysis suggests this role is
optimal for Mid candidates.
“Laboratory Instrumentation and Validation Specialist. Skills: Laboratory instrumentation, Validation, Quality systems, CGMP. Support data integrity. Support audit readiness”
Industry & Context.
Troubleshooting; Root cause analysis; Problem-solving
Lift up to 35 pounds
What They're Looking For.
Must Have
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, 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, Interpersonal skills with the ability to collaborate cross-functionally, Excellent organizational skills, attention to detail, and time management capabilities, 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, Thorough knowledge of cGMP’s, 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, Must be able to lift up to 35 pounds at times
Nice to Have
Bachelor’s degree in chemistry, engineering, or a related scientific field
What You'll Do.
Support data integrity
Support audit readiness
Support lifecycle management of electronic laboratory systems
Support lifecycle management of analytical equipment
Lead instrument onboarding
Lead computer system validation (CSV) activities
Author validation documentation
Review validation documentation
Maintain validation documentation
Perform routine troubleshooting of laboratory instruments
Perform non-routine troubleshooting of laboratory instruments
Coordinate instrument repairs
Coordinate preventive maintenance
Coordinate service activities with internal teams
Coordinate service activities with external vendors
Oversee instrument repairs
Oversee preventive maintenance
Oversee service activities with internal teams
Oversee service activities with external vendors
Support calibration programs
Support metrology programs
Contribute to deviations
Contribute to investigations
Contribute to change controls
Maintain work instructions
Maintain related documentation
Participate in internal audits
Participate in external audits
Provide documentation during audits
Provide subject-matter expertise during audits
Provide corrective action support during audits
Manage vendor relationships
Manage service contracts
Provide budgetary input for equipment lifecycle planning
Oversee daily workflow
Provide performance evaluations
Handle discipline of employee
Handle termination of employee
Ensure team compliance with training requirements
Ensure team compliance with safety programs
Ensure team compliance with GMP expectations
How You'll Work.
Team & Collaboration
Collaborate cross-functionally
Communication Scope
Written communication; Verbal communication
Process & Methodology
Resource planning
Full Job Description
## 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, dis
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