Senior Validation Engineer

Millstone Medical • Olive Branch, MS

2d

About The Position

The Senior Validation Engineer will be responsible for documenting and executing validation protocols for manufacturing equipment and processes, ensuring compliance with GMPs and regulatory requirements. This role involves developing and maintaining manufacturing work instructions, serving as a technical liaison with customers, and participating in cross-functional teams to resolve issues and drive continuous improvement. The engineer will also provide operational support, train personnel, and potentially lead projects of moderate scope. Key responsibilities include ensuring validated processes are accurately followed in production, addressing technical issues with customers, investigating root causes of problems, and mentoring junior staff.

Requirements

• Bachelor’s degree in Engineering is required.
• 4-8 years of relevant experience in validation engineering, preferably in a manufacturing environment.
• Experience with IQ, OQ, and PQ protocols is required.
• Knowledge of Good Manufacturing Practices (GMPs) is essential.
• Strong technical writing skills are required to develop and document client process validations.
• Excellent communication skills, both verbal and written, to interface effectively with customers, cross-functional teams, and operations personnel.
• Exceptional attention to detail, analytical abilities, and problem-solving skills.
• Ability to work independently and initiate/manage communications with customers.
• Ability to negotiate with clients on project timelines, processes, and validation activities.

Nice To Haves

• Experience in developing systems to improve standard processes is preferred.

Responsibilities

• Document and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for various manufacturing equipment and end-of-line processes.
• Ensure that all validations are conducted in accordance with Good Manufacturing Practices (GMPs) and meet customer and regulatory requirements.
• Develop, maintain, and update manufacturing work instructions to ensure that validated processes are accurately followed in production.
• Collaborate with operations and quality teams to ensure work instructions are clear, concise, and effective.
• Serve as a technical liaison between the company and customers, addressing technical issues, project timelines, and validation support.
• Communicate effectively with customers to manage expectations and ensure alignment on validation activities.
• Actively participate in cross-functional teams to investigate and determine the root cause of issues and develop corrective actions.
• Collaborate with Quality, Manufacturing, and R&D teams to support continuous improvement initiatives and resolve validation-related challenges.
• Provide ongoing support to operations by troubleshooting issues related to validated processes and equipment.
• Communicate effectively with Program Managers to ensure alignment on project goals and timelines.
• Train operations personnel on validated processes, work instructions, and equipment operation to ensure compliance with established procedures.
• Mentor junior engineers or technicians as needed.
• Lead projects of moderate scope and duration, including defining project scope, schedule, team roles, and responsibilities.
• Independently perform and coordinate detailed phases of engineering work, ensuring project tasks are completed on time and within budget.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior