MA Equipment Validation

  • Contractor
  • Full-Time
  • Devens
  • Splintpharma
  • Prefferd visa: OPT, CPT, F1, H4, Have H1 Visa, Need H1 Visa, EAD
  • Posted 2 months ago – Accepting applications
Job Detail
  • Offerd Salary $ 25 - $ 40
  • Required Position 2-4 hires
  • Experience 0-5 Years Required
Job Description

I have a Devens, MA equipment validation role available if you have anyone who can work onsite?
URGENT requirement 

Job description
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
- Support the implementation of a standardized global qualification for QC instrumentation and associated software across multiple BMS QC sites
- 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.
- Support general QC asset management
- Coordinate/interface with vendors for servicing/maintenance/upgrades
- Execute periodic assessments/decommissioning as needed

Qualifications and Experience Required:

- Bachelor’s degree in relevant scientific or computer area with 7 – 10 years’ experience in the biopharmaceutical industry or MS degree with 6+ years’ experience or equivalent combination of education and experience.
- Minimum 6 years’ experience in a role either (a) QC instrument qualification or (b) software validation, with detailed knowledge of regulatory requirements related to QC instruments and associated software
- Demonstrated expertise in large projects, prioritizing workload with minimal supervision
- Demonstrated ability to work independently as well as contribute to a team based collaborative environment
- 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

Job Requirement

I have a Devens, MA equipment validation role available if you have anyone who can work onsite?
URGENT requirement 

Job description
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
- Support the implementation of a standardized global qualification for QC instrumentation and associated software across multiple BMS QC sites
- 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.
- Support general QC asset management
- Coordinate/interface with vendors for servicing/maintenance/upgrades
- Execute periodic assessments/decommissioning as needed

Qualifications and Experience Required:

- Bachelor’s degree in relevant scientific or computer area with 7 – 10 years’ experience in the biopharmaceutical industry or MS degree with 6+ years’ experience or equivalent combination of education and experience.
- Minimum 6 years’ experience in a role either (a) QC instrument qualification or (b) software validation, with detailed knowledge of regulatory requirements related to QC instruments and associated software
- Demonstrated expertise in large projects, prioritizing workload with minimal supervision
- Demonstrated ability to work independently as well as contribute to a team based collaborative environment
- 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

Required skills