About the role
Validation Engineer Trainee - Attach & Train program role based on the published job description. Key responsibilities and requirements were extracted directly from the posting for quick review.
BiopharmaOnsite
Key Responsibilities
- Maintain the site's Right to Operate and enable excellence in manufacturing by providing validation support to the production organization that results in safe, high quality, and continuously improving production.
- Own, execute and improve the validation lifecycle from Plan to Retire, for manufacturing processes and equipment.
- This includes, but is not limited to oversight of Equipment, Facility, and Utility Qualification, Cleaning Validation, Shipping Validation in partnership with Distribution, and administration of the Periodic Review and Revalidation Program.
- Accountable for ensuring compliance with PQS and HA requirements.
- Support the day-to-day operation of approved Validation SOPs / Plan / Policies for a multi-platform, multi-product, GMP biotech contract manufacturing facility.
- Develop Validation SOPs, templates, guidelines, Validation Protocols and Reports including supporting site discrepancies and deviations investigation / closure in line with corporate policies and standards.
Requirements
- Degree in Life Sciences or Engineering discipline or equivalent · 0-3 years of related working experience for degree holders or equivalent holders with combination of education and relative work experience · Related working experience in a biotech or pharmaceutical operation environment is preferred · Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, GAMP and ICHQ7).
- Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility · Good oral and written communication skills ·Meticulous and Systematic · Ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule · Must be highly motivated, able to work independently as well as a Team player, with strong focus on Safety, Quality and timeline.