Validation Engineer

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Validation Engineer Validation Engineer

JOB_53137921170586

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Job type

Contract

Location

New Jersey

Profession

Pharma

Industry

Pharmaceuticals

Pay

$88.56 -$88.56/hr.

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Validation Engineer - Contract - New Jersey\ Hybrid - $88.56 -$88.56/hr.

The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking a Validation Engineer in New Jersey\ Hybrid.

Role Description

Essential Functions:

Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures.

• Develops protocols, and associated reports while adhering to a change management process.

• Supports the execution of equipment qualifications and validation protocols

• Supervises vendors for qualification functions.

• Supports equipment qualification and systems validation activities.

• Configures and documents the configuration of computerized systems

• Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.

• Manages projects of varying scope and complexity.

• Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.

• Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems

• Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.

• Completes all qualification and validation documentation with accuracy, completeness and compliance to Company standards.

• Provides excellent customer service and support.

• Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.

• Provides technical support and guidance on calibration and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.

• Maintains a positive relationship with all team members and site customers while promoting a positive team environment.

Skills & Requirements

Required Competencies-Knowledge, Skills, and Abilities:

Knowledge, Skills & Abilities:

• Strong working knowledge of MS Windows client and server technologies.

• Working knowledge of standard networking principles and technologies

• Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry

• Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance

• Ability to work with the end user to identify and document User and Functional Requirements

• Knowledge of pharmaceutical laboratory and manufacturing systems.

• Experience executing equipment qualification documents

• Ability to interact effectively with laboratory, QA, and Facilities groups

• Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously

• Strong written and verbal communication skills along solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Experience with technical writing and document development / generation

• Strong computer skills in Microsoft Office Suite - Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualification.

Competencies:

• Technical / Professional Knowledge

• Problem Solving / Troubleshooting

• Action Oriented

• Attention to Detail

• Multi-tasking

• Building Relationships

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

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.

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 committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays' guiding principles is 'do the right thing'.

We also believe that actions speak louder than words.

In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays 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 .

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

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