Commercialization & Validation Engineer
Hays

Job Info

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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.

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.

Our client is seeking a Commercialization & Validation Engineer in Manhattan , NY/ Hybrid.

Role Description

The CSA Validation SME is a key stakeholder in the ELC CSA Center of Excellence (COE). The primary function of this role is to ensure the integrity of CSA projects, with an eye to assessing risk and ensuring integrity. Their responsibilities serve as a key conduit between the COE leadership and the protocol author(s) and tester(s). The CSA Validation SME will ensure validation projects meet regulatory and data integrity requirements, and they will confirm validation projects meet R&D/GSC/IT policies.

• Provide insight and expertise on validation project risk and complexity

• Maintain validation best practices

• Gather project information from system owner(s)

• Collaborate with the Business Analyst on a frequent basis

• Maintain compliance with Good Documentation Practices (GDP)

• Aid in writing and reviewing of reports summarizing system CSA validation execution

• Collect feedback from System Owner(s) on deliverables

• Draft and execute of GxP Assessment, Risk Assessment (RA), Validation Plan (VP), Test Plan (TP), and Validation Summary Report (VSR) as necessary

• Draft, review, and execute other validation documents when necessary

Skills & Requirements

• Bachelor's Degree in Computer Science, Information Technology, Chemical Engineering, Biomedical Engineering, or related degree

• 7-10+ years of successful, progressive experience with Computer System Validation and Computer Software Assurance

• Aptitude in GAMP 5 and 21 CFR Part 11 standards

• Previous experience in a GxP industry or a life sciences industry is required

• Technical competency in FDA regulations

• Expertise in generating, reviewing, and addressing CAPAs

• Strong written and verbal communication skills

• Strong ability to collaborate with the team

• Ability to work self-directed in the timely completion of project deliverables

• Practical experience with Data Integrity and ALCOA+ is a plus.

• Strong written and verbal communication skills

• Strong ability to communicate with other COE team members

• Strong analytical and problem-solving abilities

• Understands the purpose of CSA, is passionate about customer safety, data integrity, and product quality

• Adept at solution development and project scoping

• Effectively collaborate with peers, cross-functional teams, and departments

• Strong technical background is preferred

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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#1158814 - Cameron Pierce

This job has expired.