Sagax Team
Job Title
Validation Specialist – Laboratory Systems & Instruments
Location
Germany / Netherlands / Italy
Employment Type
Full-Time
Overview
We are seeking a Validation Specialist with experience in Computer System Validation (CSV) and laboratory instrument qualification to join our client’s team in Europe. The role requires hands‑on experience of validation of computerized lab instruments. Experience in enterprise lab systems such as LIMS and Empower is a strong plus.
This position involves significant international travel (80%+) across North America, Europe, Japan, Korea, and Australia to support system validation projects at multiple sites.
Key Responsibilities
Plan, execute, and document CSV activities in alignment with GxP and regulatory guidelines.
Develop and execute protocols (IQ, OQ, PQ, UAT) for laboratory instruments and enterprise lab systems.
Support validation of computerized laboratory instruments (e.g., Empower CDS, LIMS, ELN, EM systems).
Collaborate with QC and/or Microbiology teams to ensure systems and instruments meet operational and compliance requirements.
Perform on‑site testing, data collection, issue resolution, and reporting for validation deliverables.
Ensure validation documentation is accurate, audit‑ready, and compliant with company procedures.
Partner with cross‑functional teams including IT, Quality, and business SMEs to manage validation lifecycle activities.
Qualifications
5+ years experience in Microbiology.
1+ years’ experience in Computer System Validation (CSV) in a Pharmaceutical Lab in a GMP‑regulated environment.
Prior experience validating enterprise laboratory systems (LIMS, Empower, ELN, Environmental Monitoring systems) highly preferred.
Experience with computerized instrument validation and related data integrity requirements.
Strong knowledge of GxP regulations, 21 CFR Part 11, Annex 11, and data integrity principles.
Excellent communication and documentation skills.
Willingness to travel up to 80% internationally (Europe, Japan, Korea, Australia).
Must reside near an international airport to facilitate frequent travel.
Preferred Skills
Ability to work independently across diverse cultural and operational environments.
Strong problem‑solving skills with a detail‑oriented approach.
Demonstrated ability to collaborate with IT and Quality teams to deliver compliant solutions.
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Validation Specialist – Laboratory Systems & Instruments
Location
Germany / Netherlands / Italy
Employment Type
Full-Time
Overview
We are seeking a Validation Specialist with experience in Computer System Validation (CSV) and laboratory instrument qualification to join our client’s team in Europe. The role requires hands‑on experience of validation of computerized lab instruments. Experience in enterprise lab systems such as LIMS and Empower is a strong plus.
This position involves significant international travel (80%+) across North America, Europe, Japan, Korea, and Australia to support system validation projects at multiple sites.
Key Responsibilities
Plan, execute, and document CSV activities in alignment with GxP and regulatory guidelines.
Develop and execute protocols (IQ, OQ, PQ, UAT) for laboratory instruments and enterprise lab systems.
Support validation of computerized laboratory instruments (e.g., Empower CDS, LIMS, ELN, EM systems).
Collaborate with QC and/or Microbiology teams to ensure systems and instruments meet operational and compliance requirements.
Perform on‑site testing, data collection, issue resolution, and reporting for validation deliverables.
Ensure validation documentation is accurate, audit‑ready, and compliant with company procedures.
Partner with cross‑functional teams including IT, Quality, and business SMEs to manage validation lifecycle activities.
Qualifications
5+ years experience in Microbiology.
1+ years’ experience in Computer System Validation (CSV) in a Pharmaceutical Lab in a GMP‑regulated environment.
Prior experience validating enterprise laboratory systems (LIMS, Empower, ELN, Environmental Monitoring systems) highly preferred.
Experience with computerized instrument validation and related data integrity requirements.
Strong knowledge of GxP regulations, 21 CFR Part 11, Annex 11, and data integrity principles.
Excellent communication and documentation skills.
Willingness to travel up to 80% internationally (Europe, Japan, Korea, Australia).
Must reside near an international airport to facilitate frequent travel.
Preferred Skills
Ability to work independently across diverse cultural and operational environments.
Strong problem‑solving skills with a detail‑oriented approach.
Demonstrated ability to collaborate with IT and Quality teams to deliver compliant solutions.
#J-18808-Ljbffr