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Manager, Senior Manufacturing Engineer
Ireland , Cruiserath
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Posted: 2023-01-06
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Job Overview & Requirements
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. Bristol Myers Squibb Ireland Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company’s first European biologics manufacturing facility. This state of the art facility will produce multiple therapies for the company’s growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus. BMS Cruiserath has been awarded “Biopharma Company of the Year 2019” in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020 and 2021. For more information about Bristol Myers Squibb, visit us at BMS.com/ie The Role BMS Cruiserath Biologics is seeking to recruit a permanent Manager, Senior Manufacturing Engineer. Reporting to the Lead Manufacturing Engineering SME, the Senior Manufacturing Engineer will be the System Owner for the Upstream and Downstream Process Equipment providing engineering support for Manufacturing systems and equipment. Key Duties and Responsibilities: Responsible for the Manufacturing Equipment within the Multi-Product Cell Culture (MPCC) building, including but not limited to Bioreactors, Depth Filtration, Centrifugation, Chromatography, Ultrafiltration/Diafiltration and Process Support systems. Provide support to Manufacturing with main focus on troubleshooting Equipment and Automation issues, and supporting/leading Process Equipment Investigations. Technical leader in support of systems of responsibility and accountable for changes to ensure continued compliance of the manufacturing equipment. Manage projects arising from changes and to improve equipment up times. Ensuring all the systems are in compliance with all Regulatory requirements including Quality (cGDP/GMP’s), EHS, Global Engineering, design & construction directives, requirements & procedures, as well as all Local Regulatory requirements. Supporting internal and external audits as the Manufacturing Engineering Technical resource. Responsible for Clean in Place (CIP) and Steam in Place (SIP) changes, support of Validation including periodic assessment. Accountable for redlining, reviewing and approving of Automation Functional Specifications and ensuring implementation of software changes to the PAS. Co-ordination of Maintenance activities and monitor reliability of equipment, including review and approval of Preventative Maintenance (PM), Drawing updates, and support of out of Specification investigations related to Calibration of critical equipment. Supporting and implementing new capital project scopes for equipment related modification projects on assigned systems as required, including defining User Requirements, supporting installation, commissioning, and Validation activities, ensuring equipment functions to current User Requirement Specifications. Ensure construction activities are performed to site specifications; PM programs are updated as needed, and perform design review. Perform but not be limited to the following activities: Periodic FMEA review of owned equipment, addressing equipment issues identified by production teams, assessing production needs opportunities, coordination with internal groups and outside contractors, generation of specifications for the procurement of equipment and instrumentation, installation modification of equipment and systems, reducing equipment downtime, developing and implementing new capital project scopes, project management for non-capital modification projects, support of compliance efforts related to Investigations, CAPA and change management. Champion the use of continuous improvement. Qualifications, Knowledge and Skills Required: The successful candidate will have a BS in Engineering (Chemical or Mechanical preferred) with 6 years plus experience (or equivalent) with manufacturing equipment support in the Biotechnology manufacturing industry. The individual should have the ability to manage and co-ordinate technical projects and be familiar with the manufacturing operations of large scale production facilities as well as GMP experience. Knowledgeable and experienced in engineering principles related to typical biopharmaceutical upstream and downstream processing and support equipment including but not limited to bioreactors, filtration and ultra-filtration, CIP, SIP, centrifugation, chromatography, autoclaves, and parts washers. Candidates must be effective in both a team environment and an individual contributor role with minimal supervision. Ability to work extended hours or a modified work schedule as required for coverage of 24/7 manufacturing operation. The job requires high level of technical knowledge and the candidate should have the ability to proactively troubleshoot. Knowledge of Delta V, or other process automation software required; ability to use process historian and analyze data to assist troubleshooting. Detailed knowledge and experience in Engineering Design of Process Equipment and Systems. What’s important to us Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases: Passion: Our dedication to learning and excellence helps us to deliver exceptional results. Innovation: We pursue disruptive and bold solutions for patients. Urgency: We move together with speed and quality because patients are waiting. Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments. Integrity: We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues. Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential. We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve. Why you should apply You will help patients in their fight against serious diseases You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees. You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 23.5 days annual leave plus 3 Company days, life assurance, on-site gym and gain-sharing bonus. 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.
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Job Summary
Category
Engineering
Country
Ireland
City
Cruiserath
Employment Type
Full Time
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