Description
Job Title: CSV Engineer
Job Type: Contract
Location: Copenhagen, Denmark
Job Description:
- Minimum of 8+ years of experience in a highly regulated environment: pharmaceutical, biotechnology or related industry.
- 2 to 3 years of experience in project management (preferred);
- In-depth knowledge of FDA (21 CFR Part 210 & 211, 21 CFR Part 11)and European compliance regulations (Eudralex Vol 4) and GAMP guidelines applicable to computer system validation;
- Authoring/executing/Review of Validation Deliverables viz., Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports as per the compliance requirements.
- In-depth knowledge of validation deliverables associated with each step of the computer system life cycle;
- Familiar with off-the-shelf, configurable, and custom-developed applications;
- Experience in validating automated systems used in the pharmaceutical industry: eg LIMS, SAP, Argus, Document Management System etc.,
- Possess strong analytical and decision-making skills;
- Possess excellent verbal and written communication skills;
- Position demands an individual who is willing to travel.
- Mentoring more junior members of the validation team, and for managing medium-sized to large projects independently as required.
- Responsible for participating in and contributing to team meeting and fostering knowledge exchange within the validation team and with other colleagues.
Basic Qualifications
- Bachelors degree in computer science, computer engineering, life science, or any other pertinent degree;
- Minimum of 3-4 years professional experience in pharmaceutical computer systems validation OR in computer systems quality assurance (pharmaceutical and/or consulting background).
- Technical proficiency with the Microsoft Office suite of tools required, especially Microsoft Word and Excel
- Experience with a Document management system