Validation & Compliance Engineer Contract NEW

Validation & Compliance Engineer

Kenilworth, Rahway, NJ 07065, United States

Duration: 07+ Months

Pay rate range: $50 – $58 per hour

Core Job Duties:

• 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 company’s compliance business

Basic Qualifications:

• Bachelor’s 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

Degree Requirements

Bachelor’s Degree; scientific background.

#CB

Rate/Salary: $50- $58 per hour