Validation Engineer

Validation Engineer – Contract – Princeton, NJ - $62.00-$72.00/hr
The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Pharmaceutical Company is seeking a Validation Engineer in Princeton, NJ.

Role Description

The Validation Manager manages the implementation of global enterprise level validation processes at the site level. Additionally, would be responsible and revising local procedures with global procedures and training the site in the new process.

This highly technical and highly specialized position will be part of our global project in streamlining the equipment / utility / facility / computer system qualification process. The person will be representing Devens Site and will be a conduit for the qualification feedback for the site and the global group.

• You will organize activities across different groups, ensuring completion of the project within scope and schedule requirements and also help plan and direct new workflow implementation efforts.
• Develop detailed timelines for programs, ensure they are executable and drive execution efforts to deliver on time.
• Manage program risks and ensure that mitigation strategies are in place.
• Manage data review meetings for the programs and ensure key decision points are identified and executed upon.
• Perform gap analysis and kaizen events to bring different project stakeholders’ alignment and ensure identification of gaps and driving the risk mitigation arising from them to closure;
• You will report to the Associate Director of Validation Engineering and work to support our scientific strategy by planning activities, tracking activities and holding stakeholders accountable to project tasks.
• Develop Standard Operating procedures (SOPs) and other governing documents to ensure consistent application of the requirements and strategies;
• Provide technical guidance, establishes project priorities, and schedules activities to ensure timelines and milestones are met;
• Write, review, and approves validation documents to support cleaning validation activities;
• escalates critical deviations to Quality and Site management’s attention;
• Lead cross-functional teams and provides expert guidance to associates to align with the new processes;
• Communicate effectively and promptly at all levels of the organization, supporting department objectives and management decisions;
• Able to lead matrix teams and promote a team approach to identify gaps in the future and current processes and mitigate them.

Skills & Requirements

• B.A. or B.S. degree, preferably in pharmaceutical, biotech, or engineering related field.
• Minimum 8+ years’ experience with Qualification/Validation of facilities, utilities, equipment, processes.
• Minimum 2+ years project management experience working in matrix organization.
• Strong working knowledge of GMP and industry regulatory (FDA) requirements.
• Hands-on experience in at least one of the following areas: Cleaning Validation, Process Validation, Quality System Assessments and Implementation, Auditing and Gap/GMP Assessments, Manufacturing Operations in Pharma/Biopharma, Process Engineering or Equipment, Facility and Utility Qualification.
• Strong creative problem solving and analytical skills.

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.

• Medical
• Dental
• Vision
• 401K
• Life Insurance ($20,000 benefit)

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is an Equal Opportunity Employer including disability/veteran.

In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.


Job Type
Technology & Internet Services

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