MS&T Validation Specialist

Our customer is an innovative biopharmaceutical Big Pharma company. For an on site assignment for the brand new commercial manufacturing site, the Center of Excellence for projects and New Product Introductions (NPIs) is looking for a Validation Senior Scientist is the subject matter expert in validation processes in ensuring products/processes meet regulatory requirements and quality standards. The incumbent will support all operational aspects of MS&T department including process monitoring/support, change control and deviation closure. This position regularly works cross functionally with Manufacturing, Quality, Logistics, Facilities, Drug Product Development and Vendors.

You have:

• Bachelor Degree in Engineering, Chemistry, Pharmacy or Natural Science.
• Minimum 4-6 years of experience in pharmaceutical industry
• Strong problem-solving skills, strong verbal and written communication skills.
• Project and change management experience. Experience with Product Life Cycle Management. 
• Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc.) with direct interactions including face to face interaction and response to audit questions.

Your tasks:

• Develop, implement and manage the site process validation, and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs.
• Collaborate with cross functional teams to define the interfaces to equipment qualification / utilities qualification, system qualification and analytical method validation.
• Establish and maintain the Validation Master Plan for process validation. Ensure that all manufacturing processes are validated, overview on state of validation at site is maintained.
• Participate in transfers and launches, liaise with technical development for new products and align on the product validation approach. Contribute to provide experimental data obtained during the validation activities, which will be used to prepare the related registration documentation.
• Author or reviewer for routine validation protocols and reports, associated change controls and supports the execution at the shop floor.
• Lead and drive investigation for validation related matters and implement corrective and preventive actions.
• Contribute to all relevant audit inspection and ensure inspection readiness for the site. Ensure compliance with relevant regulatory requirement, GMP, and other industry standards.
• Initiate, drive and implement continuous improvement initiatives to optimize processes, enhance produce performance and drive operational excellence for better quality, safety and efficiency.

You are able to work independently and to influence and work across organizational boundaries. You must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required. Excellent command of English and preferably French language.