Specialist, MSEO Manufacturing Systems Validation
American Cybersystems, Inc.

Summit, New Jersey
$50.00 - $57.59 per hour

Innova Solutions is immediately hiring for an MSEO Manufacturing Systems Validation Specialist
Position Type: Contract
Duration- 06 Months
Location- Summit, NJ

As an MSEO Manufacturing Systems Validation Specialist, you will:

  • Work cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing. This role is primarily an individual contributor but will routinely support project and production works.
  • Will partner with site Business Owners, CI Owners, Quality, and the global EMES team to create, manage, and improve computerized systems/Recipes validation deliverables for electronic systems, applications, and associated controls to maintain data integrity supporting ALCOA+ principles throughout the CSV lifecycle.
  • Will be responsible for ensuring the validation of the S12 Enterprise Manufacturing Execution System (EMES), and applications are done following the relevant Client procedures, such as CSV SOP but no limited and applicable health authority regulations.
The ideal candidate will have:
  • Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE) and Recipe Authoring/Validation.
  • Ability to work extended hours or a modified work schedule to assist manufacturing operations support model, including 12x7 on-call support rotation Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA+ principles of data integrity, risk-based approaches to validation,
  • Computer Software Assurance (CSA) principles
  • Understanding the concept of Critical thinking for Computerized Systems
  • Familiar with the development of CSV documentation (Validation Plans, Requirements, Design / Configuration Specifications, Test Scripts [IQ/OQ/PQ/UAT], Summary Reports, Trace Matrices, SOPs)
  • Experience with MES infrastructure, ALM and Veeva document/change management systems and middleware Web Methods
  • With advanced technical document writing and time management skills, including ability to prioritize and manage expectations
  • Operate effectively and with minimal supervision, within a team or independently, performing projects and related duties
Education and Experience:
  • Bachelor's degree in a life sciences, engineering or technology discipline required
  • Minimum of 2+ years relevant work experience required preferably in a pharmaceutical manufacturing environment.
  • An equivalent combination of education, experience and training may substitute.
We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.

Thank you!
Mohit Vyas
Sr. Associate ? Recruitment

Pay Range*: $50-$57.59 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.

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