Validation Engineer x 3

Highly Competitive
  1. Permanent
  2. Validation
  3. United States
Asheville, North Carolina
Posting date: 22 May 2019
VA.MK.23478_1558517292

A vacancy for a Validation Engineer has arisen with a leading pharmaceutical company that provides continuous service to customers in the pharmaceutical, biotechnology, medical device, diagnostics, biologics, and clinical industry. Based in North Carolina, this is an exciting opportunity to work with a renowned organization on a 6-9 month contract, with the option of extending to a longer period.

The Validation Engineer will provide hands-on validation support to several facility/utility and equipment qualifications that are planned for the site. The ideal candidate will have experience with qualification in HVAC, Clean Room Qualifications, Control Rooms, and filtration systems, as well a familiarity with Computer System Validation and Control Systems. Prior experience within a Pharmaceutical or Medical Device environment is required (GxP experience).

Job Responsibilities:

  • Creating documents required for the Qualification/Validation of Facilities, Utilities, Equipment, and computerized systems. IQ/OQ/PQ and Data Integrity (ALCOA) required.
  • Performing process validation, process capability, and process control studies for assigned areas
  • Participating in and contributing to medium to large size projects, owning assigned tasks, and producing detailed requirements and analysis documents for assigned tasks.
  • Partnering with other support groups and manufacturing teams to complete work.
  • Ensuring FDA regulations are met for system upgrades/replacements.
  • Ensuring the quality of facility Qualification and Validation packages.
  • Providing support to resolve technical issues with systems under validation.

Skills and Requirements:

  • BS degree in Engineering Discipline (ME, IE, CHE, BME, EE, CE).
  • At least 3-5+ years of experience.
  • IQ / OQ / PQ & Data Integrity (ALCOA) experience/knowledge.
  • Must have pharmaceutical or medical device experience.
  • It will be important for the individual to be able to work on days, nights, holidays, and/or weekends as needed by the project timeline to meet manufacturing deadlines.
  • Experience with installation, administration, and maintenance of servers is helpful.
  • Quality Assurance or Pharmaceutical industry experience required.
  • Candidates must meet visual acuity requirements as documented
  • Validation experience must focus around commissioning and qualifications.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Max Kelly at +312-270-1613 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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#Compliance/Quality

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