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Biotechpharma, UAB
VALIDATION ENGINEER (COMPUTERIZED SYSTEMS)
Biotechpharma, UAB
Biotechpharma, UAB

VALIDATION ENGINEER (COMPUTERIZED SYSTEMS)

Biotechpharma, UAB

Responsibilities:
• Lead computerized system qualification gap remediation project.
• Lead and maintain computerized system qualification infrastructure.
• Draft, review and approve local validation and compliance documents supporting GxP computerized systems, and relevant infrastructure.
• Coordinate, assist and document validation activities; preparation/approval of protocols and reports.
• Perform re-validation and change control validation related activities.
• Provide training to colleagues and contractors on our approach to systems implementation and validation SOP’s.
• Coordinate meetings, document issues, action items, meeting notes, and perform appropriate follow up related to CSV projects.

Requirements:
• Minimum of a Bachelor's degree in computer science, technology or life science.
• Experience in thorough testing of applications, computerized systems, changes and implementations.
• Ability to function independently, play a leadership role within a cross-functional team and address a variety of moderate to complex problems.
• Experience in GxP preferred.
• IT skills: PC servers, workstations and laptops. Microsoft environment. Work with standard current computer applications, such as word processing, spreadsheets and data bases;
• Fluent English language skills (verbal and writing).

Working at Northway Biotechpharma means interacting with intelligent and empowered people who focus on emerging technologies that are ground-breaking, exciting, and have a positive impact on humankind. Monthly salary (bruto) from 1500€- 3000€. Specific salary is offered based on work experience, competence, and compliance with other job requirements.
If this sounds like a place you would like to work, we invite you to send your resume and cover letter.

Mėnesinis bruto atlyginimasBruto/mėn.  € 1500 - 3000

Papildoma informacija: Specific salary is offered based on work experience, competence, and compliance with other job requirements

Vietovė

    Vilnius, Vilniaus apskritis, Lietuva

Laikas

  • Visa darbo diena

Kalbos

  •  Anglų
Kontaktinis asmuo
Laura Baltakiene
+37068602764

Northway Biotechpharma (www.northwaybiotech.com) is a full-service CDMO located in Vilnius, Lithuania with capabilities in cell line development, process development and optimization, and mid-size volume GMP manufacturing of biologic drug substances and drug products. We provide support for the development and production of branded biologics and biosimilars and are committed to achieving rapid project advancement by providing the highest-quality customized services that are needed by smaller biopharma companies and increasingly sought by large pharma.


Įmonės tinklalapishttps://www.northwaybiotech.com