What are the responsibilities and job description for the Senior Validation Engineer position at Millstone Medical?
Key Responsibilities
Equipment and Process Validation:
Skills Required
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.
- 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.
Skills Required
- 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.
- Technical Writing:
- 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.
- 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.