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Process Engineer, Parenteral Manufacturing

Company: Celgene
Location: new brunswick
Posted on: May 3, 2021

Job Description:

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.The Process Engineer is responsible for the execution and on-time final release of high quality clinical products within the Parenteral Manufacturing Department. The individual will strive for 'right the first time' quality of operations and maintain a high level of awareness/compliance in an evolving Regulatory environment. This position may participate in matrix based teams and/or act as department representative on assigned teams. As a proponent for change, the individual will explore areas for gains in efficiency and quality while appropriately balancing speed and risk.Responsibilities:Interacts as appropriate to assure the success of a clinical program from initial planning stages through batch releaseCreates and executes batch documentation in support of clinical parenteral manufacturing programTracks and assures all pre-requisites for batch manufacturing are released and available prior to executionAssures that all required training is currentCloses investigations and CAPA's within specified time limits.Efficiently prioritizes work and uses resources to meet designated timelinesProduces accurate and high quality deliverables for assigned projectsEstablishes and maintains a safe work environment for self and co-workersFollows all relevant procedures, protocols, batch documents, etc.Makes and acts on functional area task decisions while balancing speed, quality, and riskIdentifies and escalates technical and/or business issues promptly; ability to solve routine issues independently (with minimal supervision)Deep understanding of cGMP's as they relate to evolving domestic and international Regulatory standards coupled with an awareness of new industry developments and trendsAbility to establish effective plans for self and subordinates to manage assigned workload and projectsDemonstrated ability to manage increasing number of projects and/or projects of increased complexity and to complete routine projects independently (with minimal supervision)Ability to communicate directly, openly, and honestlyAbility to participate in and enable high performing teams by removing communication barriers and energizing the team to achieve shared goalsBuilds strong relationships and collaborates effectively with peers within the functional area and broader organization; ability to drive delivery of functional area, project, and broader organizational owned commitmentsActive participant/member of external industry organizations and/or discussion groups Demonstrated ability to identify and implement improvements to existing procedures, protocols, batch documents, etc.Demonstrated ability to provide effective training and coachingRequirements:Minimum of a Bachelor's Degree in the Sciences (Biology, Microbiology, Chemistry, Pharmacy).Engineering Degree preferred (Chemical, Biomedical)Must have 6 to 10 years of experience in a Pharmaceutical or Biotech Manufacturing organizationDirect experience in the manufacture of parenteral products (biologics a plus).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.

Keywords: Celgene, New Brunswick , Process Engineer, Parenteral Manufacturing, Other , new brunswick, New Jersey

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