Validation Engineer

Key Responsibilities

Author and configure MES recipes (preferably PharmaSuite) to support manufacturing and tech transfer projects.

Troubleshoot MES execution issues and integration with business systems on the plant floor.

Ensure compliance with corporate standards, regulatory requirements, and validated design principles.

Develop, review, and execute qualification and test plans in accordance with validation requirements.

Create and maintain recipe requirement specifications, design documentation, and test scripts.

Collaborate with process owners, global MES teams, and site engineering teams to ensure effective implementation.

Translate production process requirements into robust MES configurations.

Lead or support project-specific documentation efforts including implementation and validation plans.

Contribute to standardization efforts for global recipe templates and site-specific workflows.

Provide technical support and consultation for ongoing process improvement initiatives.

Participate in a monthly on-call support rotation (1 week per month, after-hours support required).

Qualifications

Bachelor’s or Master’s degree in Chemical, Electrical, Mechanical Engineering, Computer Science, or a related field.

5–7 years of experience in MES systems, preferably with PharmaSuite MES.

Solid understanding of batch record structures, workflow design, and exception handling.

Experience in a GMP-regulated manufacturing environment (pharmaceutical or biotech preferred).

Strong communication and interpersonal skills; able to interface across functional teams.

Self-starter with excellent problem-solving and multitasking abilities.

Proficient in writing test cases, validation scripts, and project documentation.

Familiarity with tech transfer processes and their impact on MES design and configuration.

Experience working with global teams on template and standards development is a plus.

Additional Information

Location: 100% On-site

Schedule: Full-time; Monday–Friday with some on-call responsibilities

Contract Type: Long-term contract with potential for extension