Senior Validation Scientist - Equipment Validation (R1554247-en-us)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.Position: MANAGER, SENIOR VALIDATION SCIENTISTLocation: Manati - PR - US
Prepares well-documented protocols for all processes to be qualified/validated based on corporate guidelines, procedures, FDA Regulations, and Industry current practices.
2. Coordinates the validation activities with related departments (Engineering, Manufacturing, QC/QA, Technical groups)
3. Develops and controls detailed time and event schedules for all studies/projects assigned
4. Performs qualification/validation studies as per established protocol.
5. Reports in an accurate and timely manner all the studies/project assigned in accordance with the designed protocol.
6. Evaluates process/equipment performance during the studies in order to determine acceptability, reproducibility, and control
7. Provides timely and efficient technical support to user on qualified/validated systems/processes.
8. Maintains all documentation records in accordance with cGMP's, company policies and FDA regulations.
9. Maintains an understanding of the current technical and regulatory trends in the pharmaceutical industry.
10. Proposes and formalize alternatives for enhancement to validate a process.
11. Maintainsvalidation programs in conformance with department standards and government/corporate regulation/specification.
12. Utilizes statistical tools and other techniques to assess performance of validation studies.
13. Assists management during FDA inspections by interacting with FDA/auditors during inspection or audits.
14. Provides annual revision of the validation programs covered in the validation Master Plan.
15. Update Operational procedure of equipment/system validated according to actual results.
16. Train impacted personnel by updated operational procedure.
17. Collaborates with internal /external clients as requested and or permitted by immediate supervisor.
18. Provides backup support to the Validation Lead during his/her absence and makes section decision as needed.
Qualifications & Experience
- Bachelor Degree in Pharmacy, Chemistry or Chemical / Mechanical Engineeringor any other related Science field.
- Five (5) years of experience in pharmaceutical manufacturing processes, technologies and aseptic processing equipment for Parenteral and biological dosage forms.
- Three (3) years of experience in pharmaceutical technology transfer, process improvements and troubleshooting.
- Proficient knowledge of biopharmaceutical formulation processes, Parenteral filling and syringe filling processes.
- Proficient knowledge of product and process development, manufacturing scale up, continuous process improvement and troubleshooting processes in conformance with departmental standards and in compliance with regulations.
- Detailed understanding of how Parenteral manufacturing processes are controlled and validated. •Ability to effectively manage multiple projects at the same time with minimum supervision and to incorporate a wide array of technical principles, concepts and theories in innovative ways to technology transfer and scale-up activities.
- Strong project management skills.
- Proficient time management skills, planning and organization capabilities.
- Proven ability to influence and work with people at different levels and departments.
- Proven leadership & teamwork skills, self starter, results oriented and build and maintain strong relationships with multiple groups.
- Proficient in Statistical Process Control, Process Capability and Risk Assessment/Management.Proven assessment, analytical and problem-solving skills.
- Proficient presentation skills and Technical Writing/Oral communication skills (English/Spanish).
- Proficient in cGMP's, OSHA and FDA Regulations as it applies to pharmaceutical industry.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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