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Equipment Validation Engineer

In New Jersey / United States

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Equipment Validation Engineer   

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JOB TITLE:

Equipment Validation Engineer

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Franklin Lakes New Jersey / United States

JOB DESCRIPTION:

Responsibilities:

  • Provide QA review and approval for establishment of standardized global procedures and training to the NQC teams standardizing Laboratory Data Systems (LDS) and Equipment Qualification and Software Validation.
  • Review and approve QC instrument qualification and software validation documentation, including any associated deviations ensuring root cause and robust CAPAs have been identified.
  • Review and approve global procedures at local sites considering existing local site CAPAs and procedures.
  • Support inspection/audit readiness activities related to network documentation.
  • Review and approve select, key multi-site and network deviations concerning laboratory methods.

Requirement:

  • Minimum of 5 years' experience in the (bio) pharmaceutical industry, with at least 2 years within a QA role.
  • In depth knowledge of cGMP regulations pertaining to instrument qualification, computer system validation and QC operations. Knowledge of 21CFR part 11, EU Annex 11 and GAMP regulations is desirable.
  • Data analysis to identify trends and their root causes.
  • 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.
  • Matrix team leadership a strong preference.
  • Innovative problem solving and growth mind-set is a strong preference.

Position Details

POSTED:

Sep 15, 2021

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16204865159893789

LOCATION:

New Jersey / United States

CITY:

Franklin Lakes

Job Origin:

CEIPAL_ORGANIC_FEED

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Equipment Validation Engineer    Apply

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Responsibilities:

  • Provide QA review and approval for establishment of standardized global procedures and training to the NQC teams standardizing Laboratory Data Systems (LDS) and Equipment Qualification and Software Validation.
  • Review and approve QC instrument qualification and software validation documentation, including any associated deviations ensuring root cause and robust CAPAs have been identified.
  • Review and approve global procedures at local sites considering existing local site CAPAs and procedures.
  • Support inspection/audit readiness activities related to network documentation.
  • Review and approve select, key multi-site and network deviations concerning laboratory methods.

Requirement:

  • Minimum of 5 years' experience in the (bio) pharmaceutical industry, with at least 2 years within a QA role.
  • In depth knowledge of cGMP regulations pertaining to instrument qualification, computer system validation and QC operations. Knowledge of 21CFR part 11, EU Annex 11 and GAMP regulations is desirable.
  • Data analysis to identify trends and their root causes.
  • 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.
  • Matrix team leadership a strong preference.
  • Innovative problem solving and growth mind-set is a strong preference.


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