Senior Validation Engineer

External applicants•Olive Branch, MS

About The Position

The Senior Validation Engineer will be responsible for ensuring that manufacturing equipment and processes are validated according to regulatory standards and customer requirements. This role involves developing and maintaining validation documentation, collaborating with cross-functional teams, and serving as a technical liaison with customers. The position requires strong technical writing, communication, and problem-solving skills, with an emphasis on Good Manufacturing Practices (GMPs). Depending on the level, project management responsibilities may also be included.

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 (depending on position level).
Ability to negotiate with clients on project timelines, processes, and validation activities (depending on position level).

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 manufacturing equipment and end-of-line processes.
Ensure all validations comply with Good Manufacturing Practices (GMPs) and meet customer and regulatory requirements.
Develop, maintain, and update manufacturing work instructions to ensure validated processes are followed in production.
Serve as a technical liaison between the company and customers, addressing technical issues, project timelines, and validation support.
Participate in cross-functional teams to investigate issues, determine root causes, and develop corrective actions.
Collaborate with Quality, Manufacturing, and R&D teams to support continuous improvement and resolve validation challenges.
Provide ongoing support to operations by troubleshooting issues related to validated processes and equipment.
Communicate with Program Managers to ensure alignment on project goals and timelines.
Train operations personnel on validated processes, work instructions, and equipment operation.
Mentor junior engineers or technicians as needed.
Lead projects of moderate scope and duration, including defining scope, schedule, and team roles (depending on position level).
Independently perform and coordinate detailed phases of engineering work, ensuring project tasks are completed on time and within budget (depending on position level).