Process Engineer

Bristol Myers Squibb; New Jersey; On-site; USD 57,142 - 72,516; Full time

Job summary

A biotechnology company is looking for a Process Engineer to support the production of personalized cell therapy products. You will ensure cGMP operations, interface with regulatory authorities, and lead process improvement initiatives. Ideal candidates have a Bachelor's degree in Engineering and 2+ years in a biopharmaceutical setting. This contract position offers competitive compensation ranging from $41.48 to $52.64 per hour, depending on qualifications.

Qualifications

• 2+ years of manufacturing support in biopharmaceutical industry.
• Experience with validation and licensure of manufacturing facilities.

Responsibilities

• Ensure safe and compliant cGMP operations.
• Provide technical input for production-related investigations.
• Interface with regulatory authorities.

Skills

cGMP knowledge

communication skills

strategic thinking

lean manufacturing

Education

Bachelor's Degree in Engineering or Related Discipline

Job description

Process Engineer – Contract

Join to apply for the Process Engineer role at Bristol Myers Squibb.

This posting is for a contract assignment with ASK Staffing DBA ASK Consulting to provide services to Bristol Myers Squibb.

Overview

• The Manufacturing Sciences and Technology Engineer Clinical CAR-T Engineering and Technology Support is responsible for supporting the production of personalized cell therapy products for global clinical trials. Collaborates with SMEs from the Development Group, Global MSAT Group, Supply Chain Group, Manufacturing Group, and Quality Group while providing technical support for the resolution of process deviations, evaluation and implementation of process changes, and continuous improvement support to production operations to ensure rapid, compliant, and cost-effective delivery of quality products.

Duties and Responsibilities

• Ensure safe and compliant cGMP operations.
• Maintain permanent inspection readiness and actively support regulatory inspections.
• Interface with regulatory authorities as required to support Manufacturing Operations audits.
• Foster a culture of compliance and strong environmental, health, and safety performance.
• Stay current with industry trends and standards (e.g., PDA, ISPE) and participate in best practice forums consistent with function responsibilities.
• Provide technical input and investigation support for production-related investigations, ensuring compliance with internal standards and regulatory requirements.
• Design and execute test plans and other risk mitigation exercises as part of investigations (e.g., root cause analysis and CAPAs).
• Sponsor and support change initiatives and the implementation of process improvement initiatives.
• Support Clinical Production Activities and production-related investigations, ensuring compliance with internal standards and regulatory requirements.
• Continuously monitor, anticipate and resolve issues that may arise during production.
• Interface with operators and serve as process SME. Learn procedures, analytics and document any known sensitivities.
• Work closely with Engineering/Maintenance on the design and implementation of new technology and new systems/facilities related to production process needs.
• Review and revise the content of technical documentation (investigations, changes, SOPs and batch records).
• Interact with other teams including Validation, Development, Operations, QA and Regulatory.
• Create an environment of teamwork, open communication, and a sense of urgency.
• Support the change agent in promoting flexibility, creativity, and accountability.
• Support organizational strategic goals and objectives that are linked to the overall company strategy.
• Drive strong collaboration within the plant and across the network; build trust and effective relationships with peers and stakeholders.
• Deliver results through timely and quality decision making and advice; promote a mindset of continuous improvement, problem solving, and prevention.
• Lead project teams, prepare project schedules, coordinate the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management.

Required Competencies: Knowledge, Skills, and Abilities

• Basic knowledge of cGMPs and multi-national biopharmaceutical/cell therapy regulations.
• Basic knowledge of facility/clean room design, process, equipment, automation, and validation.
• Intermediate strong verbal/written communication skills and ability to influence at all levels.
• Intermediate ability to think strategically and to translate strategy into actions.
• Intermediate ability to prioritize and provide clear direction to team members in a highly dynamic environment.
• Basic knowledge of quality by design and risk management.
• Basic experience with Operational Excellence and Lean Manufacturing.

Education and Experience

• Bachelor’s Degree required in Engineering or Related Discipline (advanced degree preferred).
• 2 or more years of manufacturing support or related experience in the biopharmaceutical industry.
• Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities.

Working Conditions (US Only)

• A. Physical / Mental Demands: Work is performed in a typical office environment, with standard office equipment available and used. May require standing and walking up to 10% of the time.
• B. Environmental Conditions: Lighting and temperature are adequate with no abnormal conditions caused by noise, dust, etc.

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 may be required to perform other job-related duties as requested by management.

Additional Job Requirements

• Lab w/ blood & animal

Compensation

The starting hourly compensation is in the range of $41.48- $52.64/hr. Final compensation and benefits will be determined by the employer of record.

Equal Opportunity

Equal Opportunity Employer — ASK Consulting is an equal opportunity employer and does not discriminate based on race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability, veteran status, or any other classification protected by law.

Privacy and Notices

California Applicant Notice — Review our Notice to California Job Applicants Regarding the Collection of Personal Information. Applicants with disabilities may request this notice in an alternative format by contacting [e-mail].

This posting does not constitute an offer of employment. All applicants must be legally authorized to work in the United States. Any offer of employment will be at-will.