Senior Manufacturing Engineer (R1544729-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.
Purpose and Scope of Position
The Senior Manufacturing Engineer is responsible for the management of multi-discipline projects, the creation/revision of engineering documentation, as well as management of external engineers and/or architects as required by each assignment. Projects range from small scale facility modifications/independent equipment to large scale, multi-discipline, complex equipment/system installations and/or major facility modifications. Also performing investigations and developing reports/responses.
The Senior Manufacturing Engineer is responsible for running cross-functional internal project teams of customer processes from initiation through project closeout and will be the primary internal and external contact regarding the day-to-day execution of the project.
Required Competencies: Knowledge, Skills, and Abilities
- Advanced knowledge of mechanical, utility and plant systems, as well as the ability to read construction and process drawings
- Basic knowledge of quality control systems, cGMP engineering design practices, facility and construction processes/equipment, manufacturing equipment project management, OSHA regulations as well as any other regulatory agencies the facility adheres to
- Basic knowledge of Lean Manufacturing principles
- Flexibility and ability to multi-task
- Strong organizational and time management skills
- Strong teamwork and facilitation skills
- Ability to solve operational problems
- Intermediate critical reasoning and decision-making skills
- Advanced written and verbal communication skills and the ability to interpret / write general business documents
- Basic knowledge of MS Word, Outlook, Excel, MS Project, PowerPoint, SharePoint, and AutoCAD
- Basic knowledge of the Pharmaceutical Industry as related to cGMP, regulatory standards, quality systems and Biotech processes
Duties and Responsibilities
- Responsible for the Manufacturing Equipment within the Aseptic Manufacturing suite, including but not limited to Compounding, Sterile and Final Filtration, Filler with Peristaltic Pumps, Load/Unload Automatic Transfer, VHP Pass Through, Vial Washer, Depyrogenation Tunnel, Capping and Vial Coding, and Lyophilizers
- Provide support to Manufacturing with 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 to improve equipment up times
- Ensure all the systems comply with all Regulatory requirements including Quality (cGDP/GMP’s), EHS, Global Engineering, design & construction directives, requirements & procedures, as well as all local regulatory requirements
- Support 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 equipment functional and engineering specifications
- Support 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 critical equipment
- Support and implement new capital project scopes for equipment-related modification projects on assigned systems as required, including defining User Requirements, supporting installation, commissioning, and Validations 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 limited to the following activities: Periodic FMEA review of manufacturing 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
- Develop, configure and optimize industrial processes from inception through to start up and certification
- Assess processes, take measurements and interpret data
- Design, run, test and upgrade systems and processes
- Perform other tasks as assigned
Education and Experience
- Bachelor’s degree required, preferably in Engineering or related science
- 5 years of relevant work experience required, preferably in a pharmaceutical or engineering environment
- Aseptic Manufacturing or related experience preferred
- An equivalent combination of education, experience and training may substitute
Working Conditions (US Only)
- The incumbent may be required to climb ladders or walk on catwalks at elevations above the floor to include walking on the roof
- The incumbent may be exposed to areas where noise levels are elevated and may require hearing protection during these times
- The incumbent may be required to walk outside for short periods of time
- The incumbent may be exposed to conditions that require safety glasses and hairnets
- The incumbent may be exposed to noise, gases, odors, and wet/slippery conditions
- The incumbent may be required to travel <10% (Domestic and International)
- Must be able to work at least 8 hours per day or longer during shutdown periods
- Requires the ability to concentrate during lengthy technical discussions
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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