Specialist, MSEO Manufacturing Systems Validation at Eclaro
Summit, NJ
About the Job
Specialist, MSEO Manufacturing Systems Validation
Job Number: 24-01159
Job Number: 24-01159
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Specialist, MSEO Manufacturing Systems Validation for our client in Summit, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview:
- The Specialist works 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.
- The Specialist 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 Client principles throughout the CSV lifecycle.
- The Specialist 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.
Responsibilities:
- Operate effectively and with minimal supervision, within a team or independently, performing projects and related duties.
Required Qualifications:
- 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 Client 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 WebMethods.
- With advanced technical document writing and time management skills, including ability to prioritize and manage expectations.
- Bachelor's Degree in a Life Sciences, Engineering or Technology Discipline.
- Minimum of 2+ years relevant work experience required preferably in a pharmaceutical manufacturing environment.
- An equivalent combination of education, experience and training may substitute.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Larah Beaniza
Larah.Robledo@eclaro.com
(332) 209-4549
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.