Senior Validation Engineer at Millstone Medical

Fall River, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

17 Jun, 26

Salary

0.0

Posted On

19 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Equipment Validation, Process Validation, IQ, OQ, PQ, GMPs, Manufacturing Work Instructions, Technical Liaison, Root Cause Analysis, Corrective Actions, Continuous Improvement, Troubleshooting, Project Management, Technical Writing, Problem-Solving, Mentoring

Industry

Medical Equipment Manufacturing

Description

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. Skills Required: * Education: * Bachelor’s degree in Engineering is required. * Experience: * 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. * Technical Writing: * Strong technical writing skills are required to develop and document client process validations. * Communication and Problem-Solving: * 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. * Independence and Leadership (Depending on Position Level): * Ability to work independently and initiate/manage communications with customers. * Ability to negotiate with clients on project timelines, processes, and validation activities. * Experience in developing systems to improve standard processes is preferred.

Responsibilities

The role involves documenting and executing validation protocols (IQ, OQ, PQ) for equipment and processes in compliance with GMPs, and developing/maintaining manufacturing work instructions. Additionally, the engineer will serve as a technical liaison for customers and participate in cross-functional teams to resolve issues.