Equipment Validation Engineer

Job Opening for Equipment Validation Engineer, NJ, Client: Bristol Myer Squibb
We are currently working on below mentioned Job Opening for Equipment Validation Engineer, NJ, Client: Bristol Myer Squibb. Please let me know if you are interested in applying for the same.

Client: BMS
Rate: $40
Duration: 6+ months
Interview: Phone
Onsite role, rate is not able to go higher. 3-5 years experience is ok, more junior.
 

Responsibilities will include:
- Participate as part of a cross functional global project to qualify QC instruments and associated software.
- Create, execute and review network led QC instrument/software qualification documents in support of global QC projects such as:
o Network QC Instrumentation Standardization and Windows 10 upgrades.
o Deployment of Enterprise Empower3 FR5 to QC sites including requalification of associated QC instruments.
- Support the implementations of a new standardized global qualification for QC instrumentation and associated software across five BMS QC sites.
- Implement validation strategies for QC instrumentation and associated software, across BMS QC Laboratories.
- Author qualification related deviations, identifying root causes and robust CAPAs.
- Author qualification related change controls and validation plans.
- Update BMS procedures and documents to implement data integrity controls arising from instrument qualification programs.
- Serve as liaison with lab-IT teams to harmonize QC instrument’s software configurations where applicable
- Ensure compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, lifecycle management, and computer system validation.
- Provide updates on qualification status, project timelines, and escalate challenges as required.
- Assist Network QC Equipment Lifecycle Lead in schedule development and workload management of project team.

Qualifications and Experience Required:
- Bachelor’s degree in relevant scientific or computer area with 3 - 5 years’ experience in the biopharmaceutical industry or MS degree with 2 years’ experience or equivalent combination of education and experience.
- Minimum 2 years’ experience in a role either (a) instrument qualification or (b) software validation, with detailed knowledge of regulatory requirements related to QC instruments and associated software
- Demonstrated expertise in large projects
- Demonstrated ability to work independently as well as contribute to a team based collaborative environment and prioritize workload with minimum supervision as part of supporting multiple complex projects.
- Self-directed with a high degree of professional integrity, organization, and attention to detail.
- Strong interpersonal, oral and written communication skills are essential, including the ability to communicate at all levels with clarity and precision.
- Ability to work on multiple complex team projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
- Ability to travel when required.

Job Opening for Equipment Validation Engineer, NJ, Client: Bristol Myer Squibb
We are currently working on below mentioned Job Opening for Equipment Validation Engineer, NJ, Client: Bristol Myer Squibb. Please let me know if you are interested in applying for the same.

Client: BMS
Rate: $40
Duration: 6+ months
Interview: Phone
Onsite role, rate is not able to go higher. 3-5 years experience is ok, more junior.
 

Responsibilities will include:
- Participate as part of a cross functional global project to qualify QC instruments and associated software.
- Create, execute and review network led QC instrument/software qualification documents in support of global QC projects such as:
o Network QC Instrumentation Standardization and Windows 10 upgrades.
o Deployment of Enterprise Empower3 FR5 to QC sites including requalification of associated QC instruments.
- Support the implementations of a new standardized global qualification for QC instrumentation and associated software across five BMS QC sites.
- Implement validation strategies for QC instrumentation and associated software, across BMS QC Laboratories.
- Author qualification related deviations, identifying root causes and robust CAPAs.
- Author qualification related change controls and validation plans.
- Update BMS procedures and documents to implement data integrity controls arising from instrument qualification programs.
- Serve as liaison with lab-IT teams to harmonize QC instrument’s software configurations where applicable
- Ensure compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, lifecycle management, and computer system validation.
- Provide updates on qualification status, project timelines, and escalate challenges as required.
- Assist Network QC Equipment Lifecycle Lead in schedule development and workload management of project team.

Qualifications and Experience Required:
- Bachelor’s degree in relevant scientific or computer area with 3 - 5 years’ experience in the biopharmaceutical industry or MS degree with 2 years’ experience or equivalent combination of education and experience.
- Minimum 2 years’ experience in a role either (a) instrument qualification or (b) software validation, with detailed knowledge of regulatory requirements related to QC instruments and associated software
- Demonstrated expertise in large projects
- Demonstrated ability to work independently as well as contribute to a team based collaborative environment and prioritize workload with minimum supervision as part of supporting multiple complex projects.
- Self-directed with a high degree of professional integrity, organization, and attention to detail.
- Strong interpersonal, oral and written communication skills are essential, including the ability to communicate at all levels with clarity and precision.
- Ability to work on multiple complex team projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
- Ability to travel when required.