Validation Support Specialist

Validation Support Specialist

The Validation Support Specialist executes qualification and validation activities for autoclaves and washers used in manufacturing operations. This role follows pre-approved IQ/OQ/PQ protocols, accurately records data and documents results in accordance with Good Documentation Practices, and supports equipment qualification and validation efforts in a regulated manufacturing environment. The position offers an opportunity to gain experience and establish a career within a large pharmaceutical manufacturing setting.

• Execute autoclave qualification and validation activities in alignment with approved protocols and established procedures.
• Perform washer qualification and validation cycles to ensure equipment operates reliably and meets defined specifications.
• Follow and execute pre-approved IQ/OQ/PQ protocols with a high level of accuracy and compliance.
• Accurately record data and document results in accordance with Good Documentation Practices (GDP) and internal documentation standards.
• Support equipment qualification and validation efforts for manufacturing operations by assisting with test execution and data collection.
• Verify that validation activities are completed according to established procedures, protocols, and regulatory expectations.
• Maintain accurate, organized, and up-to-date validation documentation for audits, reviews, and ongoing operations.
• Collaborate with validation and manufacturing teams to support project timelines and ensure validation tasks are completed on schedule.
• Identify and communicate documentation discrepancies or protocol deviations promptly to the appropriate stakeholders.
• Assist with data entry and documentation updates related to validation and qualification activities.
• Demonstrate willingness to learn new processes and tools to support evolving validation and manufacturing needs.

• Minimum of 1 year of experience in pharmaceutical, biotechnology, or other regulated manufacturing environments.
• Experience operating autoclaves and/or washers in a manufacturing setting.
• Ability to follow detailed written procedures and protocols accurately and consistently.
• Understanding of Good Documentation Practices (GDP) and their application to validation activities.
• Strong attention to detail and organizational skills when handling validation data and documentation.
• Self-motivated mindset with a strong work ethic and commitment to completing tasks thoroughly.
• Ability to learn new processes quickly and apply training to day-to-day validation work.
• Capability to work independently when needed while still collaborating effectively with cross-functional teams.
• Previous experience in validation, commissioning, qualification, or quality support activities.
• Exposure to IQ/OQ/PQ activities in a GMP-regulated environment.
• Experience working in GMP-regulated environments and understanding of basic GMP principles.
• Proficiency in data entry with a focus on accuracy and completeness.

• Demonstrated willingness to learn and adapt to new validation tools, systems, and procedures.
• Ability to communicate clearly and professionally with validation and manufacturing team members.
• Comfort working with technical documentation and validation protocols.
• Strong sense of ownership and accountability for assigned validation tasks and documentation.
• Interest in building a long-term career in validation, quality, or manufacturing support within the life sciences industry.
• Previous involvement in equipment qualification projects or quality support initiatives is beneficial.

This role is fully onsite Monday through Friday in a GMP-regulated pharmaceutical manufacturing environment. Standard daytime hours are expected, with no routine overtime anticipated. The position involves working around manufacturing equipment such as autoclaves and washers and handling technical documentation and data entry tasks. You will collaborate closely with validation and manufacturing teams in a structured, process-driven setting that emphasizes compliance, accuracy, and safety.

The environment offers an opportunity to gain valuable…