Senior Engineer Compliance Technical Services

Senior Engineer Compliance Technical ServicesApply locations Boudry – CH time type Full time posted on Posted 27 Days Ago job requisition id R1586900Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.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.Position SummaryThe Sr. Engineer Compliance owns and leads all the Technical Services team on all QA aspects to ensure compliance with regulations and BMS site rules. He/she supports the Sr. Manager Methods, Engineering, Reliability and C&Q in monitoring quality and performance Website is the single contact point for Technical Website QA Events for Technical Services team.Manage deviations, CAPAs, Change, IA, Findings, PI, QRA, DIRA investigations within TS teams.Act as a liaison between TS, MS&T and QA to ensure alignment on quality issues.Maintain logs and documentation for quality events and ensure timely resolution.Prepare as coordinator and assist for internal and external cGxP audits, ensuring compliance.Quality Risk Management and Mitigation: Identify potential risks related to quality events within the technical services activities and work with teams to implement mitigation strategies.Quality Continuous Improvement Initiatives: Support or lead initiatives aimed at improving TS processes with a focus on enhancing quality compliance and operational efficiency.Qualification Knowledge for all QA events in qualification.Training compliance: Ensure staff are trained on QA procedures and regulatory requirements.Ensure equipment and systems are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.Review validation documents, including requirement specifications, qualification/validation plans, protocols, reports, traceability matrix and summary reports.Contribute to the development and maintenance of the local site Website risk assessments and risk management Website change controls and maintenance interventions, evaluating the impact upon qualified systems & validated processes, and documents required actions.Support the team in proactively monitoring quality, safety and performance/reporting metrics.Autonomous; completes work independently, seeking guidance on complex tasks and on non-routine decisions.Reporting RelationshipSr. Manager Methods, Engineering, Reliability and C&QQualificationsBS/MS in Relevant science/Engineering/Technical discipline or equivalent in work experience.Experience – Responsibility and minimum number of years5 years’ QA experience in the pharmaceutical industry.5 years’ Manufacturing or technical experience on the shop floor.Competencies – Knowledge, Skills Abilities:Strong knowledge of current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP.Good ALCOA & Data Integrity knowledge.Good knowledge of IT systems (Software and Hardware).Knowledge of pharmaceutical facilities (including HVAC and utilities), manufacturing and laboratory equipment/systems and computerized system validation (CSV).Knowledge of pharmaceutical qualification, calibration and maintenance activities.Familiar with QA processes and compliance aspects.Communicates pro-actively and collaboratively.Proactively identifies problems and recommends solutions. Team player: ability to interact effectively with team and customers.Good English level; ability to communicate in French is preferred.Strong verbal and written communication skills.Strong analytical, problem-solving, influential and deductive skills.Capability to work with short deadlines and simultaneous activities. #J-18808-Ljbffr