Validation Engineer
Hays

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.

Role Description

The Validation Engineer supports the successful implementation of laboratory equipment and systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with facility, utility, and equipment qualification. With minimum supervision and given general instructions, this individual independently carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.

DUTIES AND RESPONSIBILITIES
• Manage projects of limited scope and complexity.
• Author and execute commissioning/qualification/validation deliverables including assessments, plans, system requirements, protocols, traceability matrices, and summary reports for manufacturing equipment, systems, utilities, and facilities.
• Author protocol deviations, investigate out of specification results, perform corrective and preventive actions, and execute change controls.
• Provide excellent customer service and support. Maintain a positive relationship with all team members and site customers while promoting a positive team environment.

Skills & Requirements

REQUIRED COMPETENCIES:

Knowledge, Skills & Abilities:
• Excellent technical writing skills and proficiency with Microsoft Word formatting functions; ability to efficiently create technically accurate documents for system lifecycle deliverables in alignment with the site validation program; highly attentive to spelling, grammar, punctuation, and overall document quality.
• Process oriented with solid critical thinking skills; adaptive and able to develop new/improved strategies, approaches, and procedures
• Strong understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry.
• Familiarity with 21 CFR Part 11 compliance.
• Experience writing Standard Operating Procedures, Work Instructions/Practices, and Risk Assessments for pharmaceutical production processes and/or manufacturing equipment, systems, utilities, and facilities.
• Experience authoring and executing commissioning/qualification/validation deliverables including plans, system requirements, protocols, traceability matrices, and summary reports for manufacturing equipment, systems, utilities, and facilities.
• Preferred experience executing temperature/humidity mapping qualifications for controlled storage areas, controlled temperature units (incubators, refrigerators, freezers), and cryogenic storage systems
• Preferred experience executing airflow visualization qualifications (smoke studies) for biological safety cabinets, isolators, and controlled manufacturing areas
• Experience writing protocol deviations, investigating out of specification results, performing corrective and preventive actions, and executing change controls.
• Ability to interact effectively with cross-functional 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, including solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals and drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors.
• Strong computer skills in Microsoft Office Suite - Word, Excel, Power Point, Outlook and Teams, and the ability to learn new software as required. Preferred experience with Blue Mountain Regulatory Asset Manager and Veeva Vault applications.

EDUCATION AND EXPERIENCE

a. BA/BS degree required, BS or more advanced degree in science/engineering preferred
b. Minimum 4 years of equipment qualification execution and technical writing experience in FDA - regulated industry (pharmaceutical/medical device/biotechnology

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 813.336.5570.

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

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#1167657 - Laurie McComb