Johnson & Johnson

Quality Assurance, CSV Engineer

Johnson & Johnson

full-time

Posted on:

Location Type: Hybrid

Location: Beerse • Belgium

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About the role

  • Assure that all Computer System Validation related regulatory requirements are fulfilled during the complete life cycle of computerized systems (concept, project, operational and retirement phase).
  • Act as Process Owner for Computer System Validation management.
  • Review and approve CSV documents such as SOPs, user requirements, risks analysis’s, validation plans, test scripts, changes, deviations etc…) in order to maintain compliance to regulations, guidelines, J&J policies and standards.
  • Maintain a current knowledge of international laws, guidelines and new evolutions related to CSV through courses, conferences, seminars, internal and external benchmarking and literature studies.
  • Implement this knowledge to maintain and improve CSV at J&J IMSC.
  • Prepare for audits and inspections by regulatory agencies, customers and internal compliance team.
  • Be the spokesperson for CSV related matters during audits and inspections.
  • Perform and follow up on internal and external audits to accomplish regulatory compliance.
  • Cooperate with engineering, IT and other teams for the introduction of new systems and processes and for the complete life cycle of the equipment.
  • Give advice and support for the preparation of CSV related activities and guard the cGMP aspects in new projects.
  • Be a member of multi-functional teams to realize cross-departmental objectives.

Requirements

  • Master scientific degree or equivalent experience.
  • 3 years’ experience in the pharmaceutical industry.
  • Knowledge of cGMP/CSV compliance (21 CFR Parts 11, 210, 211; Eudralex 4, EU Directive 2003/94/EC, EU Directive 2017/1572 and annex 11; GAMP, Data Integrity Guidelines)
  • Experience with Computerized System Validation.
  • Strong ownership and quality attitude.
  • You are able to deliver on commitment timelines.
  • Ability to make risk-based decisions.
  • Understands the business implications regarding quality positions and decisions.
  • Fluent in verbal and written communication in English and Dutch and are able to connect with diverse partners.
Benefits
  • You work in a dynamic team in an international and innovative environment with room for personal and professional development.
  • You have the possibility to gain experience in a variety of tasks with focus on your talents.
  • Your work is of high importance to supply products to our patients.
  • You work in a company that cares for the world and its people!
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Computer System ValidationcGMP compliancerisk analysisvalidation planstest scriptsauditsregulatory compliancedata integrityGAMPpharmaceutical industry experience
Soft Skills
strong ownershipquality attitudecommitment to timelinesrisk-based decision makingbusiness implications understandingverbal communicationwritten communicationcollaborationcross-departmental teamworkspokesperson abilities
Certifications
Master scientific degree