Senior Specialist, Associate Aseptic Process Validation Engineer

Career Areas Career Stories Join Talent Community Candidate Login English English Italiano Español Français Português Norsk Deutsch 日本語 Bahasa melayu 中文 (简体) 中文 (繁體) 한국어 ภาษาไทย Nederlands Polski Yкраїнська Hrvatski Ελληνικά Magyar čeština Türkçe Pусский Haitian עברית Brazilian Português Dansk Suomi Svenska Français (Canada) Português (Portugal) Careers Home Life at BMS Career Areas Student Opportunities Events How We Recruit Career Stories Search this site Join Talent Community Candidate Login English English Italiano Español Français Português Norsk Deutsch 日本語 Bahasa melayu 中文 (简体) 中文 (繁體) 한국어 ภาษาไทย Nederlands Polski Yкраїнська Hrvatski Ελληνικά Magyar čeština Türkçe Pусский Haitian עברית Brazilian Português Dansk Suomi Svenska Français (Canada) Português (Portugal) Single PositionView All JobsSenior Specialist, Associate Aseptic Process Validation EngineerDevens - MA - USApply NowFind out how well you match with this jobUpload your resumeJob descriptionLife at BMSWorking 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. 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. Read more: careers.bms.com/working-with-us.At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.The Senior Specialist, Associate Aseptic Process Validation Engineer, Cell Therapy provides process aseptic validation support to the Devens Cell Therapy Facility (CTF). The Senior Specialist supports the aseptic process validation program for the Devens Cell Therapy Facility (CTF).Shifts Available:Monday – Friday, Standard Working HoursResponsibilities:Responsible for supporting the execution of Aseptic Process Simulations/ Validations (APS/APV) and Aseptic Performance Qualifications.Authors qualification/validation documents (e.g. procedures, protocols and summary reports) and ensures Manufacturing readiness for APS execution.Participates in/Leads aseptic risk assessments and authors associated summary reports.Authors product impact assessments for Personnel and Environmental Monitoring-related deviations.Leads/Owns site Change Controls as requiredSupports investigations and global change controls as requiredEnsures safe and compliant cGMP operations, maintains permanent inspection readiness, and actively supports regulatory inspections as a Subject Matter Expert.Serves as a MS&T representative on cross-functional and multi-site teamsBuilds and maintains effective collaborative relationships across the site and network, influencing site and network product/process life cycle programsKnowledge and Skills:Experience in cGMP’s and multi-national biopharmaceutical/cell therapy regulationsExperience in aseptic processing/validation and facility/clean room design.Experience with internal and health authority auditsExcellent verbal/written communication skillsBasic Requirements:Knowledge of science generally attained through studies...