Validation Engineer
American Cybersystems, Inc.

Job Info

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Innova Solutions is immediately hiring for a Validation Engineer

Position type: Full-time Contract
Duration: 06 Months
Location: Summit, NJ 07901 (Onsite)

As a Validation Engineer, you will:
The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this is tasked with commissioning and qualifying new equipment facilities, utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures. The individual participates in projects and ongoing work activities of low to moderate complexity. With minimum supervision and given general instructions, this individual 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.

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

Knowledge, Skills, and Abilities:
• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
• Experience in the qualification of cell therapy equipment a plus
• Advanced knowledge of pharmaceutical, manufacturing and laboratory systems.
• Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.
• Excellent interpersonal skills with experience dealing with a diverse workforce.
• Strong multi?tasking ability in conjunction with proven organizational skills. 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.
• Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.

Education and Experience:
• BS in Engineering or Science related discipline required
• Minimum of 5 years' experience performing/supporting activities in a GMP environment.
• Minimum of 3 years' experience in equipment, facility or utility qualification

Duties and responsibilities:
1) Maintains qualified equipment systems in compliance with policies, guidelines and procedures: a. Develops qualification protocols, and associated reports while adhering to a change management process.
b. Supports the execution of equipment qualifications and validation protocols.
c. Supervises vendors for qualification functions.
d. Develops written procedures for calibration and preventive maintenance of equipment.
e. Supports equipment qualification and validation activities.
f. Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.

2) Manages projects of limited scope and complexity within their functional area:
a. Supports equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
b. 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.
c. Completes all qualification and validation documentation with accuracy, completeness and compliance to standards.

3) Provides excellent customer service and support:
a. Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.
b. Provides technical support and guidance on equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
c. Provides technical support and guidance on equipment and computer systems qualification and validations issues.
d. Maintains a positive relationship with all team members and site customers while promoting a positive team environment.

4) Regulatory Responsibilities
a. Ensure equipment, facilities and programs are maintained in compliance.
b. May be called upon as SME in both internal and regulatory audits.

Vinay Bhatiya
Associate- Recruitment

PAY RANGE AND BENEFITS:
Pay Range*: $74.00 - $77.00 per hour.
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS:Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:

• One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
• ClearlyRated® Client Diamond Award Winner (2020)
• One of the Largest Certified MBE Companies in the NMSDC Network (2022)
• Advanced Tier Services partner with AWS and Gold with MS

Website: https://www.innovasolutions.com/

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

Thanks,

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