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Validation Engineer

Remote:

Full Remote

Contract:

Full time

Salary:

29 - 29K yearly

Experience:

Expert & Leadership (>10 years)

Work from:

New Jersey (USA), United States

Offer summary

Qualifications:

12-15 years of Validation Compliance experience, Tech/Engineering/MBA or equivalent degree, Experience in Application Maintenance and Development, Understanding of pharma GxP environment, Knowledge of ISO standards for Pharmaceuticals.

Key responsabilities:

Lead the architecture, design, and development of solutions
Ensure adherence to quality standards and compliance measures
Review architecture and design deliverables according to best practices
Train and develop the team for skill enhancement
Manage customer relationships and expectations during projects

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities:

To spearhead the architecture, design, and development (through a high-performing team) of innovative solutions for product project and sustenance delivery, ensuring alignment with strategic objectives.
To ensure knowledge up-gradation and work with new technologies so that the solution is current and meets quality standards and the client requirements.
To review architecture and design deliverables and ensure solutions adhere to industry best practices, architectural standards simultaneously establish and enforce governance or compliance measures.
To train and develop team to ensure that there is an adequate supply of trained Client in the said technology and delivery risks are mitigated.

Requirements:

Validation Lead (Onshore)Must have Skills12-15 years of Validation & Compliance experience-Tech/Engineering/MBA or equivalent degree Proven experience in Application Maintenance and Development, Validation Testing scope of work, Audit Management, CAPA and Deviation Good understanding of pharma GxP environment and enabling emerging technologies for GxP.
Compliance Knowledge in establishing standards such as ISO 13485, ISO 9001 & ISO14971 guidelines for Pharmaceuticals, Biopharma and Medical devices in IT service industry. Understanding of the regulated software development life cycle (SDLC) as per GAMP5, GDPs, 21 CFR Part 11 and Annex 11 compliance Maintaining customer relationship and manage expectations and escalation Of Project Management, around Governance, Demand Management.
Estimation & Sizing Good to have Skills Proactive and problem-solving mentality with strong analytical skills Good written and verbal communication skills to effectively communicate with technical and business users self-motivated individual with a genuine passion for Compliance & Validation Role.
To bridge the gap between client needs and business goals by gathering requirements, crafting innovative solutions with deep domain technology expertise, and driving successful implementations that propel strategic initiatives.