Validation Engineer Trainee - Attach & Train program

The Position

The purpose of this role is to maintain the site’s Right to Operate and enable excellence in manufacturing by providing validation support to the production organization. You will own, execute, and improve the validation lifecycle from plan to retire for manufacturing processes and equipment, including equipment qualification, cleaning validation, and shipping validation.

Key Responsibilities

• Support day-to-day operation of validation SOPs and policies for a GMP biotech facility.
• Develop validation protocols, reports, and SOPs while managing discrepancies and deviations.
• Provide technical guidance and serve as a subject matter expert (SME) for validation activities.
• Ensure all validation activities are completed in compliance with corporate policies and regulatory standards.
• Participate in troubleshooting, training, and site audits, including regulatory inspections.
• Support change implementation and contribute to continuous improvement initiatives using lean production systems.

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 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.