FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in validation processes, including IQ, OQ, PQ, and compliance with cGMP standards. Proficient in developing protocols, analyzing validation data, and maintaining documentation for manufacturing systems and equipment.
Highest-signal resume keywords
Validation Protocol DevelopmentGMP ComplianceData Analysis and ReportingCalibration and Maintenance ManagementTeam Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Validation StudiesPreventive MaintenanceCalibrationData AnalysisValidation ReportingSOP DevelopmentThermal MappingQuality AssuranceRegulatory ComplianceValidation Standards
Soft Skills
Critical ThinkingProblem-SolvingOrganizational SkillsCommunication SkillsTeamwork
Tools & Technologies
Data Acquisition SystemsThermal Monitoring Equipment
Certifications & Qualifications
ASQ CertificationCMRT Certification
Industry Keywords
Good Manufacturing PracticesGMP-Regulated EnvironmentValidation StandardsManufacturing SystemsQuality Control
About the role
Key responsibilities & impact- Ensure equipment and system readiness through validation, calibration, and preventive maintenance
- Schedule and perform validation studies for production, requalification, IQ, OQ, PQ, CV, and PV requirements
- Instruct personnel in other departments regarding validation activities
- Advise production managers and supervisors on validation activities and adapt schedules to production requirements
- Coordinate validation activities with R&D, Manufacturing, Quality, Instrumentation, GMP, and Engineering
- Develop qualification and validation protocols and reports for manufacturing systems, processes, equipment, facilities, utilities, temperature-controlled areas, and cleaning
- Evaluate and analyze validation data for adequacy and regulatory compliance
- Perform validation-related activities involving production, calibration, maintenance, and quality
- Perform pre- and post-calibrations of thermal monitoring equipment, place probes, and generate data reports and graphs
- Perform routine requalifications, including writing protocols, performing validation runs, analyzing data, writing reports, and assembling final validation packets
- Maintain accurate and detailed documentation and ensure departmental paperwork is complete
- Assist GMP, Quality, and production personnel during internal or regulatory inspections and audits
- Coordinate or lead creation of SOPs for new equipment, including operational, maintenance, and calibration aspects
- Maintain oversight of facility equipment requiring preventive maintenance and calibration
- Oversee SOPs for existing equipment to ensure preventive maintenance and calibration requirements are documented
- Liaise with manufacturing and third-party providers to ensure maintenance and calibration are completed
- Provide validation support to all GBS locations and processes
Requirements
What you’ll need- BS/BA degree in a related field, such as STEM (Science, Technology, Engineering, and Mathematics)
- An equivalent combination of education and experience may be considered based on business need
- Minimum 5 years in validations within a GMP-regulated manufacturing environment
- Experience in maintenance and calibrations highly valued
- Strong knowledge of current Good Manufacturing Practices (cGMPs), operating procedures, validation standards and guidelines, and standard operating procedures
- Certification in validation or maintenance management (e.g., ASQ, CMRT) is a plus
- Strong critical thinking and problem-solving skills
- Ability to identify errors and provide corrective action
- Ability to work with others in a team environment
- Proficiency with data acquisition systems and thermal mapping tools
- Strong quantitative, analytical, organizational, and communication skills
- Ability to lead projects and proactiveness required
Benefits
Comp & perks- Up to 8% of the company bonus pool
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- PTO
- Paid holidays
- Up to 5% 401(K) match
- Tuition reimbursement
- Opportunities for professional growth and career progression
- Family-like culture