Requirements: English
Company: Panda International
Region: Leiden , South Holland
An international biopharmaceutical company is seeking an Interim Quality Equipment Specialist to provide quality oversight for equipment lifecycle activities across manufacturing, laboratory, and facility environments. Based in Leiden, Netherlands, this is a hybrid role with 23 days on site per week and strong potential for extension beyond the initial 6-month term.
Key Details:
- Start Date: ASAP
- Contract Duration: 6 months (extension likely)
- Location: Leiden, Netherlands (Hybrid: 23 days onsite/week)
- Languages: English required
- Commitment: Ideally full-time
- Interview Process: Fast-track
Responsibilities
- Lifecycle Documentation Oversight Review and approve documentation such as URS, DQ, IQ, OQ, PQ, and change controls for equipment and systems.
- Cross-Functional Collaboration Work with Engineering, CQV, and Maintenance to ensure equipment meets intended use and quality standards.
- Compliance Risk Management
- Ensure equipment qualification complies with cGMP, FDA, EMA, ISO, and ICH guidelines.
- Participate in equipment-related risk assessments (e.g., FMEA).
- Monitor and trend equipment-related quality data and recommend improvements.
- Maintenance Calibration Oversee calibration and maintenance practices, ensuring alignment with procedures and data integrity (ALCOA+).
- Deviation CAPA Support Manage and resolve equipment-related deviations, CAPAs, and change controls in a timely and compliant manner.
- Audit Support Provide documentation and subject matter expertise during audits and inspections.
Requirements
- Bachelors degree in Engineering, Life Sciences, or a related technical field.
- 35 years of experience in quality, validation, or engineering within the pharmaceutical, biotech, or medical device industry.
- Strong knowledge of cGMP, FDA 21 CFR Part 11, ISO 13485, ISPE, and ASTM E2500 standards.
- Hands-on experience with equipment qualification and validation across labs, manufacturing, or facilities.
- Familiarity with CMMS, calibration systems, and quality systems such as TrackWise or Veeva.
- Excellent attention to detail, problem-solving, and communication skills.
Preferred:
- Experience with Computerized Systems Validation (CSV)
- Familiarity with automation systems (e.g., PLC, SCADA)
- Knowledge of data integrity expectations
- Green Belt or similar continuous improvement training
- Experience with or knowledge of systems including:
- NC-202
- Prodigy
- CytoFLEX
- Endosafe
- ELLA
- dPCR
- BioFire
Why This Role?
- Hands-On Impact Be the go-to expert ensuring compliance, reliability, and readiness of critical equipment.
- Multi-Disciplinary Exposure Collaborate across engineering, QA, labs, and manufacturing.
- Fast-Paced Environment Engage in ongoing audit support, equipment optimization, and regulatory alignment.
- Long-Term Potential Strong likelihood of contract extension based on project demand.
Interview Process
- 2 Interviews
- Start Date: ASAP