Digital Platform Senior Validation Engineer

Randstad Enterprise; University City (MO); Sur place; USD 75 000 - 150 000; Plein temps

Résumé du poste

Une entreprise leader dans la fabrication pharmaceutique recherche un Ingénieur de Validation Senior pour diriger les projets de validation des plateformes numériques. Ce rôle exige une expérience dans la validation logicielle ainsi qu'une expertise en conformité réglementaire. Les candidats doivent posséder un diplôme en sciences de la vie ou en ingénierie et avoir au moins 5 ans d'expérience pertinente. Les responsabilités incluent la gestion de l'intégrité des données et la participation aux audits, tout en garantissant la conformité aux normes GMP, GCP et GLP.

Qualifications

• Diplôme en sciences de la vie ou en ingénierie requis.
• 5+ ans d'expérience en validation logicielle.
• Expérience avec la conformité réglementaire et les systèmes numériques.

Responsabilités

• Diriger les projets de validation pour les produits numériques.
• Réaliser des évaluations de risque et des rapports de validation.
• Gérer les plaintes des clients et les audits.

Connaissances

GMP

GCP

GLP

GAMP

Communication

Formation

Bachelor's degree in Life Science or Engineering

Outils

Word

Excel

PowerPoint

SharePoint

Description du poste

Digital Platform Senior Validation Engineer

Digital Platform Senior Validation Engineer

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In this role, you will be the Digital Platform Senior Validation Engineer. This position is responsible for the guidance and direction of validation projects covering all the Life Science digital products, applications, and computerized systems. Your primary focus will be creating automated devices and instrumentation that facilitate chemical synthesis and sample preparation, ensuring these systems are robust, precise and scalable.

Responsibilities include but not limited to:

• Reviews regulatory requirements based on the systems need and scope of target market and internal and external use in GMP and Non-GMP areas.
• Performs 21 CFR Part 11, Annex 11, Risk Assessments, Functional risk assessments, Data Integrity Assessments, FMEA to ensure the requirements, controls are captured prior to development and ensure tested system/products met those requirements.
• Develops Test Summary Report, Traceability Matrix, Validation Summary Reports, QMS, Data Integrity White papers, IQ, OQ Protocols, FAT and management of deviation and observation.
• Leads the Operational Change Control, deviation, CAPA management, customer complaints handling, periodic review, and re-validation of multiple digital products and software applications. Actively participating as auditee presenting and explaining validation and qualification documents or reports to the regulatory, customer auditors and internal and external auditors.

Who You Are:

Minimum Qualifications:

• Bachelor’s degree in Life Science (Chemistry, Biology etc) or Engineering, (Chemical, Mechanical etc) or Computer Science.
• 5+ years software or computerized validation experience.

Preferred Qualifications:

• Experience with Project Planning, Word, Excel, PowerPoint and SharePoint.
• Experience with GMPs, GCPs, GLPs, GAMP and Part 11 compliance as they relate to qualification of systems in support of validation of processes

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance and Engineering

• Industries

  Pharmaceutical Manufacturing

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