Validation Specialist - 3200, 3201
West Point, PA 19486 US
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
Title: Validation Specialist (CSV)
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: 10+ month contract (possible extensions)
- Pay rate: $58.07/hr
- Job Location: West Point, PA
- Job#: bh14623
Validation Specialist (CSV)
In order to set expectations and to the extent permitted by applicable law, please note that if an applicant is hired for this position, the applicant will be required to prove that the applicant has been fully vaccinated against COVID-19 by the date of hire, subject to any qualified religious or medical exemptions. Please note that the employer reserves its rights to mandate additional vaccine requirements at any time.
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
- 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
- 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
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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