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Specialist, MSEO Manufacturing Systems Validation-Hybrid

Posted about 1 month ago

  • Expiry Date: 25 September 2023
  • Referral:

"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".

About Our Client: Our Client is a differentiated company, led by our unique BioPharma strategy that leverages the reach and resources of a major pharma company paired with the entrepreneurial spirit and agility of a biotech firm. We work every day to deliver innovative medicines for patients with serious and life-threatening diseases.

Each day, our employees around the world work together for patients—it drives everything we do. We are focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience, and fibrosis. Through our Research & Development organization, we have built a sustainable pipeline of potential therapies, and actively partner to access external innovation to broaden and accelerate our work.

As global citizens, we work sustainably and responsibly and seek to give back. Through the company Foundation, we promote health equity and strive to improve health outcomes of populations disproportionately affected by serious diseases and conditions, giving new hope to some of the world’s most vulnerable people.

Basic Qualifications for Consideration:

  • 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 ALCOA+ 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 procedures, such as CSV SOP but no limited and applicable health authority regulations.

Required Competencies:

Knowledge, Skills, and Abilities:

  • 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 WebMethods

  • 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.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.