Specialist, MSEO Manufacturing Systems Validation

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.

Thank you!

Mohit Vyas

Sr. Associate ? Recruitment

PAY RANGE AND BENEFITS :

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).