Sr. Validation Engineer (Pharma)

  • Location
    Raleigh, North Carolina
  • Job type
    Direct Hire
  • Category
    Engineering - Bio-Medical

Adecco Executive Recruitment is currently on the hunt for a Sr. Validation Engineer (QA) for its client in Raleigh. As a SME (Subject Matter Expert) for site compliance related functions including Validation, you will

author, execute, and summarize validation protocols.
be responsible for coordinating and leading validation project execution for equipment, critical utilities, cleaning validation, and computer related systems.
ensure protocols, records, and procedures are in compliance with cGMP and approved SOPs.
support investigations for critical equipment, processes, and utilities.

ESSENTIAL FUNCTIONS:


Coordinate and execute validation studies, writing protocols, and documenting results.
Generate summaries of work for release of equipment tested.
Troubleshoot protocol deviations and summarize actions in a report format.
Develop/revise new or existing procedures to insure compliance to cGMP, GLP, and regulations.
Provide technical advice on new equipment or utilities.
Ability to assess statistical process data
Provide insight into modification of existing equipment to ensure validation/qualification status is maintained in a state of control.
Knowledge and experience in general validation activities such as URS, FS, DS, FAT, SAT, IQ/OQ/PQ
Understand the fundamentals of steam sterilization, cleaning validation, and equipment qualification.
Understand equipment such as autoclaves, formulation/hold tanks, and filling/packaging equipment trains.


You have (required):

Bachelor's degree in Engineering/Life Sciences with at least 7 years’ experience within the pharmaceutical industry
Previous experience in Validation or Engineering
Ability to utilize MS Office (Word, Excel, Powerpoint, Access)


Preferred Skills/Qualifications:

CSV SME
Experience in product contact cleaning including the use of swabs and plates
Knowledge of GAMP4/5 and application of Risk Based approaches to Validation
Able to balance resources, voice of the customer, and timelines, while implementing robust and defendable validation doctrines
ValProbe and Kaye Validators experience
Ability to comprehend and apply principles of calculus, modern algebra, and advanced statistical theory
Ability to define problems, collects data, establish facts, and draw valid conclusions from these observations
Industry guideline knowledge of 21 CFR part 11, 21 CFR part 210, 21 CFR part 211, IPSE, PDA, MHRA, PICs, MFDS

APPLY NOW for immediate consideration.
RELOCATION ASSISTANCE WILL NOT BE PROVIDED
karen.newell@adeccona.com


  • Apply with Adecco

Reference number US_EN_2_027442_136919