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Validation & Compliance Engineer

Hamilton, NJ 08611

Posted: 06/06/2023 Employment Type: Contract Job Category: Engineering Job Number: 567280-1 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 40-58.07/hr **salary will be commensurate with experience 

Job Description: 
  • Design, Author, and Execute Computerized System Validation (CSV) - according to GAMP 5 guidance - especially on Analytical Laboratory Test Equipment and other Lab Information Systems
  • Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents
  • Open up Change Controls is TrackWise
  • Create and update and route SDLC documents in MIDAS
  • Execution of SDLC documents on site
  • Route executed and reviewed Acceptance Testing and Change Control Test Plans
  • Translate technical information and requirements into qualification/validation test design
  • Contribute to the overall growth of compliance business

Basic Qualifications:
  • Bachelors Degree; scientific background
  • At least 5+ years of pharmaceutical of FDA related validation experience

Preferred Skill & Experience:
  • Good knowledge of GMPs, 21CFR Part 11, USP 1058 - and other relevant industry regulations and guidance
  • Strong interpersonal skills and demonstrated ability work independently
  • Organized and task oriented
  • Excellent written and oral communication skills - especially on technical topics
  • Self-directed and motivated individual who is able to operate in a rapidly changing business environment
  • Customer-oriented, conducting job function with a primary focus on customer satisfaction (internal & external) and ability to deal with customer complaints
  • Must have a strong command of Microsoft Office Word and Excel and Adobe Acrobat, Microsoft Project
  • Ability to build consensus among team of stakeholders
  • Excellent critical thinking/analytical and problem solving skills
  • Experience with a multitude of laboratory equipment a plus

Other Requirements:
  • Must be able to remains in a stationary position more than 50% of the time
  • The person in this position needs to occasionally move inside and outside labs and follow Personal Protective Equipment and Safety Polices
  • Frequently operate on instruments, objects, tools or controls, which will require regularly bending, squatting, stretching and reaching in order to perform in a service function.
  • Occasionally move or lift up to 25 pounds
  • Specific vision abilities required by this position include without limitation, the ability to observe details at close range (within a few feet of the instrument), distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus in order to perform the essential service functions of this position.
  • Regularly operates a computer and other office machinery, such as a calculator, copy machine, and computer printer

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Hamilton, NJ

Discover exciting job opportunities in the vibrant area surrounding Hamilton, New Jersey! Nestled in the heart of Mercer County, this charming town offers an ideal blend of suburban tranquility and urban energy. With its close proximity to Princeton University, renowned art galleries like Grounds For Sculpture, and bustling theaters like the George Street Playhouse, Hamilton is brimming with cultural attractions. Not to mention, food enthusiasts can indulge in the region's diverse cuisine scene, from classic diners to trendy bistros. Explore career growth in this thriving community, home to professional sports teams like the Trenton Thunder and scenic parks like Veterans Park. Embrace the enchanting charm of Hamilton, NJ, as you embark on a fulfilling career journey in this inviting locale. Start your job search today and unlock endless possibilities in this dynamic region!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.