About this role
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.