Lead Engineer, Equipment Commissioning & Qualification

Bristol Myers Squibb EU Policy; South Hadley Falls (MA); On-site; USD 88,000 - 107,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Programs

401(k) Plan

Job summary

Bristol Myers Squibb is seeking a Lead Engineer, Equipment Commissioning and Qualification (ECQ) Delivery to drive commissioning and qualification of new equipment, utilities, facilities and lab instruments at multi-use sites. You will work with internal stakeholders and external vendors to ensure on-time, compliant execution.

With minimal supervision, you will manage qualification projects, develop protocols, supervise vendors, and ensure final qualification and validation deliverables meet BMS

Qualifications

• BS in Engineering or science; relevant experience accepted.
• Minimum 4 years GMP experience.
• Minimum 3 years equipment/utility qualification.
• Minimum 2 years GMP project management experience.

Responsibilities

• Maintain qualified equipment systems in compliance with policies and procedures.
• Develop qualification protocols and associated reports.
• Execute equipment qualifications and validation protocols.
• Supervise vendors for qualification functions.
• Support development of equipment operational procedures.
• Support equipment validation activities.
• Develop validation/qualification deliverables and reports.
• Support Change Management processes.
• Manage equipment implementation projects: scheduling, site prep, installation, and turnover.
• Lead internal customers in operation, calibration and maintenance.
• Oversee contract project teams to ensure timely, compliant execution.
• Complete all qualification/validation documentation accurately.

Skills

cGMP/GXP knowledge

Pharma/manufacturing systems

CAPA & investigations

Communication skills

Interpersonal skills

multitasking & organization

Office software proficiency

Task management in GMP

Education

B.S. in Engineering or related

4+ years GMP experience

3+ years equipment/utility qualification

2+ years GMP project management

Job description

Bristol Myers Squibb is seeking a Lead Engineer, Equipment Commissioning and Qualification (ECQ) Delivery to drive commissioning and qualification of new equipment, utilities, facilities and lab instruments at multi-use sites. You will work with internal stakeholders and external vendors to ensure on-time, compliant execution.

With minimal supervision, you will manage qualification projects, develop protocols, supervise vendors, and ensure final qualification and validation deliverables meet BMS