Senior Validation Engineer

Millstone Medical • Fall River, MA

1d

About The Position

Key Responsibilities:

Equipment and Process Validation:
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.
Manufacturing Work Instructions:
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.
Customer Interface:
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.
Cross-Functional Team Participation:
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.
Operational Support:
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.
Training and Development:
Train operations personnel on validated processes, work instructions, and
equipment operation to ensure compliance with established procedures.
Mentor junior engineers or technicians as needed.
Project Management (Depending on Position Level):
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.

Requirements

• Bachelor’s degree in Engineering is required.
• Depending on the level of the position, 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.
• Serve as a technical liaison between the company and customers, addressing technical issues, project timelines, and validation support.
• Actively participate in cross-functional teams to investigate and determine the root cause of issues and develop corrective actions.
• Provide ongoing support to operations by troubleshooting issues related to validated processes and equipment.
• Train operations personnel on validated processes, work instructions, and equipment operation to ensure compliance with established procedures.
• 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: Mid Level
• Number of Employees: 101-250 employees