Senior Scientist, MS&T Validation

BMS - Bristol-Myers Squibb

Boudry, Switzerland

Validation Senior Scientist is the subject matter expert in validation processes in ensuring products/processes meet regulatory requirements and quality standards. You will support all operational aspects of MS&T department including process monitoring/support, change control and deviation closure.

Your main responsibilities are

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;
Develop the strategy for continued process verification that ensures all critical process parameters and quality attributes are monitored or analysed, and actions are defined and taken in case of trends or deviations. Reviews plans for CPV;
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.

Qualifications & Experience

Bachelor Degree in Engineering, Chemistry, Pharmacy or Natural Science;
Minimum 4-6 years of experience in pharmaceutical industry with MSc degree or 7-9 years’ experience with BSc and in GMP validation activities are considered an asset;
Strong problem-solving skills, strong verbal and written communication skills;
Ability to work independently and to influence and work across organizational boundaries;
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;
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.

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