Pharma Validation Software Engineer/Lead in Ukrany

Requirements:

• This will be a role that will combine the two. We are looking for someone who has the skills to lead a team, but can "roll up their sleeves" and work "in the field". It is not pure management role, nor pure Software engineering role.
• Must to have at least 5-6 years
• Must to have experience with Pharma industries is a must-mandatory
• Must to have to have expériences as Lead and mentor a team through the system lifecycle, utilizing expert knowledge in risk management;
• Must to have be familiar with regulatory compliance specifically related to validation, validation protocols, risk management and industry standards.
• We are looking for someone with a strong technical profile for the role, however the Pharmaceutical Validation Manager role requires candidates with significant hands-on experience in validation processes, including process validation and regulatory compliance specifically related to validation. The ideal candidate should have a thorough knowledge of validation protocols, risk management and industry standards as described in the JD.
• Senior Pharma Validation Engineer or still Pharma Validation Engineer Lead /Engineer: clearly there is ambiguity, but we are looking for a Pharma Validation Engineer/ Lead. A person with a good technical background and understanding of the healthcare domain.
• The position of Validation Manager in the pharmaceutical sector requires candidates with significant hands-on experience in validation processes, including process validation and regulatory compliance specifically related to validation. The ideal candidate should have a thorough understanding of validation protocols, risk management and industry standards as described in the JD.
• Review and approve validation deliverables for GxP-regulated computerized systems to ensure compliance with regulatory requirements and company policies;
• Support internal and external Health Authority regulatory audits;
• Provide CSV guidance and support to project and business teams, resolving validation documentation corrections and test defects;
• Review and approve validation test scripts, compliance plans, user requirements, system tests, traceability matrices, and compliance reports;
• Ensure inspection readiness for systems in the CSV portfolio, minimizing risk of inspection observations;
• Lead and mentor a team through the system lifecycle, utilizing expert knowledge in risk management;
• Define internal standards for positive risk management using best practices;
• Own, revise, and maintain CSV SOPs;
• Maintain knowledge of company policies, 21 CFR Part 11, Data Integrity, ICH Q7A, and GAMP principles;
• Assist in preparing and maintaining Quality System documentation and SOPs for computer system validation.

Start: asap, Full remote

Duration: 12 months+ potential extension

Working time: 9:00am – 6pm EET