Senior Process Engineer

Bristol-Myers Squibb; Indianapolis (IN); On-site; USD 70,000 - 120,000; Full time

Job summary

An established industry player is seeking a Senior Process Engineer to manage engineering support for production operations. This role involves executing maintenance and calibration activities while implementing improvement projects for process equipment. You will collaborate with high-achieving teams to optimize operations that transform patient lives. The company offers a supportive environment with opportunities for growth, emphasizing balance and flexibility. If you're passionate about making a difference in the biotechnology field, this position could be your next career step.

Benefits

Flexible work hours

Health care plans

Retirement savings plan

Employee assistance programs

Professional development opportunities

Qualifications

• 5+ years of hands-on experience in plant maintenance in GMP facilities.
• Ability to manage and execute maintenance and calibration activities.

Responsibilities

• Manage new asset installation and configuration.
• Lead troubleshooting efforts for equipment issues.
• Develop and maintain technical documents for process equipment.

Skills

GMP Pharmaceutical experience

Project management

CMMS systems knowledge

Electrical systems knowledge

Vendor management

Education

BS in Engineering

AAS in Engineering

Tools

MS Office Suite

PLC control systems

Job description

Working with Us
Challenging. 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 .

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Summary

The Senior Process Engineer will manage engineering support activities for production operations including management and execution of maintenance and calibration activities. The Senior Process Engineer will provide technical expertise to support the operation and maintenance of all process equipment. Further, the Senior Process Engineer will implement improvement projects to the process equipment including design, execution and hand-over within cost, time schedule, quality and functionality specification.

Job Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

· Manage and execute new asset installation and configuration

· Manage investigation and troubleshooting efforts in case of equipment issues or failures

· Maintain asset inventory within CMMS

· Maintain calibration, preventive maintenance, and corrective maintenance programs

· Develop and maintain spare parts requirements for process equipment

· Develop, revise, and maintain technical documents for process equipment and GMP risk assessments.

· Interpret P&IDs, equipment/system layouts, wiring diagrams and specifications and manage revisions.

· Own and drive process equipment and procedures deviations, root cause analysis investigations, and CAPAs.

· Reviews equipment and engineering systems to support data collection, root cause analysis investigations, and trend investigations.

· Lead continuous improvement efforts to increase asset reliability including asset modifications.

· Coordinate and execute of assigned projects.

· Support commissioning, qualification, and validation activities when applicable

· Provide technical support during Startup, PQ and validation activities

· Support change requests/change control as needed

· Support internal and external audits.

Education and Experience

· BS in Engineering discipline and 5+ years of hands-on experience leading and executing plant maintenance and calibration activities in a GMP manufacturing facility.

· Or AAS in Engineering discipline and 10+ years of hands-on experience leading and executing plant maintenance and calibration activities in a GMP manufacturing facility.

Skills and Qualifications

· Experience in the GMP Pharmaceutical or Medical Device industry is required

· Experience in pharmaceutical aseptic manufacturing is preferred

· Experience with isolators is preferred

· Basic knowledge of Environmental Monitoring, Building Automation, and CMMS systems and architecture is required.

· Vendor management experience is preferred

· Experience managing projects is preferred

· Must be able to adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (FDA, USP, OSHA, etc.)

· Proficiency with MS Office Suite

· Working knowledge of electrical, automation systems and robotics

· Must be willing to work around radioactive materials.

· Familiarity with PLC control systems and instrumentation bus technologies.

· Must be flexible to work weekends, and holidays as required

Physical Demands

· Ability to climb ladders and lift up to 50 lbs.

This is a position that requires working in a GMP cleanroom environment, wearing protective clothing, and handling of radioactive materials.

The noise level in theworkenvironment is usually moderate.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail] . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

W e’re creatinginnovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.