Specialist, MSEO Manufacturing Systems Validation

Minimum 50% onsite required every week. The Specialist works cross‑functionally to execute validation activities and prepare validation deliverables for the 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 work.

The Specialist partners 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. The goal is to maintain data integrity supporting ALCOA principles throughout the CSV lifecycle. Responsibilities include ensuring validation of the S12 EMES and applications is performed in accordance with relevant BMS procedures—CSV SOP, applicable health authority regulations, and GDPR/21

CFR part 11 electronic records and signatures.

• Sound understanding of Electronic Batch Records (E ) and Review by Exception (RBE) and Recipe Authoring/Validation.
• Ability to work extended hours or a modified work schedule to assist manufacturing operations support, including 12×7 on‑call rotation.
• Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21
  
  CFR part 11 electronic records, electronic signatures, and good documentation practices with ALCOA principles and risk‑based approaches to validation.
• Understanding 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.
• Advanced technical document writing and time management skills, including prioritizing and managing expectations.
• Operates effectively with minimal supervision, both within a team and independently, performing projects and related duties.

• Bachelor’s degree in a life sciences, engineering, or technology discipline required.
• Minimum of two years relevant work experience, preferably in a pharmaceutical manufacturing environment.
• An equivalent combination of education, experience, and training may substitute.

The assignment is a contract assignment with ASK Staffing DBA ASK Consulting to provide services to Bristol Myers Squibb. The starting hourly compensation range is $55–$57.59 per hour. Final compensation will be determined by the employer of record, ASK Staffing, Inc.

ASK Staffing provides comprehensive ACA‑compliant health coverage, along with dental, vision, short‑ and long‑term disability for eligible employees. Additional benefits include commuter benefits, a 401(k) plan with no matching, a referral bonus program, unpaid leave, and paid sick leave as required by law.

ASK Staffing is an equal opportunity employer and does not discriminate against employees or applicants based on race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability, veteran status, or any other classification protected by federal, state, or local laws.

ASK Staffing is committed to complying with the California Privacy Rights Act (CPRA) and all relevant data privacy laws in the jurisdictions where we recruit and hire. Applicants with disabilities may request this notice in an alternative format by contacting

To comply with federal, state, and local fair chance ordinances, we consider qualified applicants with arrest or conviction records. The background check will evaluate whether any criminal history could reasonably pose a direct, negative impact on job‑related safety, security, trust, regulatory compliance, or overall suitability for the role. Findings that raise concerns may result in withdrawal of a conditional job offer.

Submissions of intentionally false or fraudulent information may disqualify candidates. Any eventual offer of employment will be considered at the time of the offer, regardless of the expected assignment duration.