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Sr. Validation Specialist in Manatí at BetterJobs

Date Posted: 3/13/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Manatí
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    3/13/2019

Job Description

Company Description

Validation & Engineering Group (V&EG) is a leading services supplier with almost 20 years' of technical expertise providing solutions for the Pharmaceutical, Biotechnology, Chemical,  and Medical Devices industries in the following areas: Laboratory, Regulatory Compliance, Computer System, Engineering, Project Management, Validation, and other services in USA and Puerto Rico.



Job Description

The Sr. Validation Specialist/Engineer will be working with the Validation team developing and executing validation activities and protocols.  The selected candidate must be knowledgeable and experienced in the following:

-Experience in pharmaceutical facilities qualification in a manufacturing environment.

-Background in pharmaceutical products in a manufacturing environment.

-Experience in the validation requirements, activities, and deliverables for the design, implementation, and operation of Freeze-Thawing Units.

-Strong knowledge of cGMP regulations.

-Good technical documentation skills.

-Must be an expert at the entire validation life cycle:

  • Facilities commissioning
  • URS
  • SAT/Report
  • Initial Risk Assessment
  • Validation Plan
  • Design Specifications
  • SOPs
  • IOQs
  • Final Risk Assessment
  • Traceability Matrix
  • Validation Plan Summary Report


Job Requirements

Qualifications

Required Experience:

  • 5 to 10 years of experience in the pharmaceutical or biotechnology  industry.
  • Capable of working independently with minimal supervision, and communicating.
  • Great technical writing and communication skills
  • Effective interpersonal and problem solving skills
  • Commissioning and Qualification
  • Protocols Generation and Execution
  • Must be proficient using MS Windows and Microsoft Office applications.
  • Strong knowledge in regulatory guidance as well as understanding of how they are applied to regulatory compliance, i.e. FDA guidelines, cGMP, 820, OSHA, 21 CFR Part 11, and other related CFR's, ISPE Good Automated Manufacturing Practice (GAMP).
  • Must be available to work extended hours and rotating shift as required.

Required Education:

  • Bachelor's Degree in Science or Engineering (Chemical, Electrical, Computer, Industrial or Mechanical) preferred.


Additional Information

Positions available for Puerto Rico.

Validation and Engineering Group, USA Inc. is an Equal Employment Opportunity employer.