Overview
Quality Equipment Consultant Jobs in Leiden, South Holland, Netherlands at Planet Pharma
Quality Equipment Specialist Contractor
Duration: A 6 month contract wit possibility of extension. Full Time- 40 hours weekly
Company: A Global Pharmaceutical Company
Location: 2/3 days in Leiden
Project Scope:
We are seeking a Quality Equipment Specialist Contractor to provide expertise in equipment lifecycle management, ensuring compliance with regulatory standards, internal procedures, and industry best practices. This role involves oversight and support across selection, design, commissioning, qualification, calibration, maintenance, and decommissioning of equipment used in manufacturing, laboratories, and support systems.
Your Mission
Provide quality oversight and approval for equipment lifecycle documentation, including URS, DQ, IQ, OQ, PQ, and change control.
Collaborate with Engineering, CQV, and Maintenance teams to ensure equipment meets intended use and quality standards.
Review and approve commissioning and qualification protocols and reports, ensuring compliance with cGMP regulations and relevant guidelines (e.g., FDA, EMA, ISO, ICH).
Ensure critical equipment and instrumentation are properly calibrated and maintained in accordance with established procedures.
Participate in risk assessments (e.g., FMEA) related to equipment and process qualification.
Support deviations, CAPAs, and change control processes, ensuring timely resolution.
Monitor and analyze equipment-related quality data, recommending improvement actions as needed.
Ensure data integrity and adherence to ALCOA+ principles within equipment documentation and systems.
Support audits and inspections by providing relevant equipment documentation and subject matter expertise.
Job Requirements
Who You Are:
Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
3–5 years of experience in quality, validation, or engineering roles within the pharmaceutical, biotech, or medical device industry.
Strong knowledge of cGMP regulations, FDA 21 CFR Part 11, ISO 13485 (if applicable), and industry guidance (ISPE, ASTM E2500).
Experience with laboratory, manufacturing, and/or facility equipment validation and qualification.
Working knowledge of calibration systems, CMMS, and quality systems (e.g., Track Wise, Veeva).
Strong attention to detail, problem-solving skills, and effective communication abilities.
Preferred:
Experience with computerized systems validation (CSV).
Familiarity with automation systems (e.g., PLC, SCADA) and data integrity requirements.
Green Belt or other continuous improvement training is a plus.
Beneficial Equipment Knowledge:
NC-202
Prodigy
Cyto Flex
Endosafe
ELLA
dPCR
Bio Fire
Title: Quality Equipment Consultant
Company: Planet Pharma
Location: Leiden, South Holland, Netherlands
Category: Engineering (Quality Engineering, Biomedical Engineer, Process Engineer), Quality Assurance – QA/QC (Quality Engineering)
