Validation Engineer Trainee - Attach & Train program

The Position

The Validation role is responsible for maintaining the site’s Right to Operate and ensuring manufacturing excellence by providing validation support. The role involves managing the validation lifecycle from planning to retirement for manufacturing processes and equipment, including qualification of facilities, utilities, and cleaning processes, while ensuring compliance with PQS and HA requirements.

Key Responsibilities

• Support daily operations of validation SOPs and policies in a GMP biotech facility.
• Develop validation protocols, reports, and SOPs, and manage discrepancy investigations.
• Provide technical guidance and serve as a subject matter expert (SME) for validation activities.
• Ensure all validation activities are completed in accordance with standards and timelines.
• Participate in troubleshooting, training, and audit support, including regulatory inspections.
• Support change implementation and contribute to site-wide continuous improvement initiatives.
• Adhere to all safety, health, environmental, and security requirements.

Qualifications

• Degree in Life Sciences, Engineering, or an equivalent discipline.
• 0-3 years of related experience, preferably in a biotech or pharmaceutical environment.
• Familiarity with regulatory requirements and standards such as FDA, EMEA, GAMP, and ICHQ7.
• Strong knowledge of validation programs in GMP facilities.
• Excellent communication skills with a meticulous and systematic approach.
• Ability to adapt to changing priorities and work effectively both independently and as part of a team.