Equipment Engineer

Overview

Equipment Engineer, Equipment Commissioning & Qualification Operations at Bristol Myers Squibb. Supports the successful operation of laboratory, clinical and commercial manufacturing operations at the home site through interaction with internal teams, customers and external service providers.

Responsibilities

• Execute equipment calibration, preventative maintenance, performance verification and repair activities in both laboratory and manufacturing areas.
• Supervise vendors for calibration, preventive maintenance, performance verification and repair functions.
• Review and approve vendor اجراted calibration, maintenance, repair, and performance verification records for accuracy, completeness and compliance to Bristol-Myers Squibb standards.
• Enter data into the site CMMS system and ensure records are filed appropriately after approval.
• Write and support deviations and participate in corrective and preventive actions related to calibration or performance verification failures.
• Develop, revise and review written procedures for calibration, preventive maintenance and performance verification of equipment.
• Develop, review and approve calibration and maintenance plans including asset induction requests/modifications in the CMMS system.
• Support execution of equipment performance verification and process improvement studies.
• Adhere to policies and procedures to ensure compliance to high standards.

Qualifications

• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21 CFR Part 11, computer systems validation requirements and good documentation practices.
• Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
• Strong written and verbal communication and interpersonal skills; ability to work with a diverse workforce and within a team.
• Strong multi-tasking and organizational skills; ability to manage multiple tasks in a high-paced environment.
• Proficiency in Microsoft Office Suite and databases; ability to learn new software and systems.
• Working knowledge of scheduling software and inventory management systems (e.g., Blue Mountain RAM).
• Ability to interact effectively with laboratory, QA and Facilities groups.

Education and Experience

• BS in Engineering or Science related discipline preferred.
• Minimum 2 years' experience in FDA-regulated industry.
• Experience with bench-top manufacturing and laboratory equipment (cell counters, liquid handlers, Flow Cytometry, UPLC, HPLC, etc.) preferred.
• Knowledge of cGMP in the pharmaceutical industry.
• Strong problem-solving, written and verbal communication skills; ability to work independently and with others.
• Maintenance coordinating/planning experience in a laboratory environment (2 years recommended).
• Experience in a commercial environment preferred.

Duties and Responsibilities

• Operational Activities: include calibration, PM, performance verification and repair; vendor supervision; record review and approval; data entry into CMMS; documentation and change control support.
• Customer Service: provide technical support on calibration and verification; respond to customer requests and maintain positive relationships with stakeholders.
• Inventory Management: coordinate with planning to update systems after calibration and maintenance activities.
• Regulatory Responsibilities: maintain required training; adhere to safety procedures; may act as SME in internal/regulatory audits.

Working Conditions

• Occasional physical tasks, up to 25 lbs; ability to sit/stand/walk for extended periods.
• Primarily laboratory or GMP environment; required PPE and gowning as appropriate.
• Ability to work safely alone or with others.

The starting compensation for this job ranges from $63,690 to $77,200, plus incentive cash and stock opportunities (based on eligibility). Final compensation decisions are based on demonstrated experience. Benefits details are available on the careers site and may vary by job and location.

On-site protocol and accommodation information: site-essential vs hybrid roles; disability accommodations are available, and inquiries can be directed to Equal Employment Opportunity statements apply. Vaccination guidance and California-residents information are available on the careers site.