SENIOR VALIDATION ENGINEER/ MANAGER (2x)

About us

Our client is the global number one manufacturer of choice for their partners who are looking for the highest quality and best service in the field of Orthobiologic Ceramics. We are working with the leading companies in the medical & dental (device) industries, start-ups with compelling business ideas and engaged universities. We co-op with our customers in the United States, Europe, Asia and in Emerging Markets. We will continue to seek and deploy technological and engineering advancements. The environment is innovative, energetic and full of opportunity. Our company thrives on a diverse workforce. Due to growth in our clients company, we are looking for a Senior Validation Engineer / Manager to lead and manage our process & validation team.

As a Senior Validation Engineer / manager within a fast-growing contract development and manufacturing organization you will be mainly responsible for developing new production processes and maintain and optimizing existing processes. The Senior Validation Engineer/manager ensures all systems are running according to necessary specifications and operate within regulations to ensure the production of quality products.

About the role

• Lead the development and implementation of manufacturing processes for complex product development
• Manufacturing lead for the transfer of manufacturing for development projects, including evaluation of processes to improve COG’s and efficiency 
• Specify and source process equipment, packing materials, and other equipment and materials to support manufacturing and product development for expansion and commercialization including automation
• Ensures that validation plans are in compliance with ISO (ISO13485) and other regulatory compliance requirements
• Maintains the validation program; schedules, files, and records (Validation year plan)
• Validating/ Qualifying the systems used to develop and/or manufacture products within manufacturing facility 
• Ensure systems are running according to necessary specifications and operate within regulations to ensure data integrity and production of quality products
• Schedules and executes validations/ qualification per Standard Operating Procedures (SOP’s) and regulatory guidelines
• Executes equipment, facility, utility, and computer system validation studies to include protocol preparation, scheduling, protocol execution, analyze, data and compose a final report
• Conducts statistical assessment for process validation and control
• Plans, performs, and directs process validations, IQ, OQ, PQ (Process validation matrix)
• Interfaces with Production, Quality and Engineers to review processes, determines validation requirements and coordinates the validation
• Coordinates and performs testing relating to the validation

Who are you?

• A Bachelor or Master’s degree in material sciences (Chemical technology or related) or comparable level through experience
• 8- 12 years relevant (international) experience within Engineering in the Medical Devices industry or the Pharmaceutical industry
• Highly motivated, Quality driven and above all a team player
• Fluently English (verbal and written) (Dutch is a plus)
• Experience in; plan, schedule, organize, prioritize, and coordinate assigned tasks
• Experience in working in a highly regulated environment 
• Experience with ISO 13485 and or GMP 
• Ability to function in a leadership role, as well as in a team environment
• Experience and comfortable to making decisions within assigned authority

Interested

If you think this sounds like your ideal new challenge, or if you have questions regarding this position we kindly ask you to contact ROBERT WHITE Staffing Solutions BV via email : info@robertwhite.nl or call +31(6) 46 70 92 18 and ask for Robert de Wit