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MES Syncade Validation Lead

Devens, MA 01434

Posted: 03/30/2023 Job Number: 23513983

Job Description

100% Onsite 6 months RTH position

Must Have:
  • Delta V Batch
  • MES Manufacturing Execution Systems
  • Process Controls System
  • S88 coding and batch processing operations

Required Skills:
  • B.S. Degree in Chemical Engineering and Science or a related discipline, or its equivalent.
  • Technical skills with Biopharmaceutical processing including 5+ years of experience developing and/or testing process automation system software (preferably Delta V batch).
  • Understanding of S88 coding and batch processing operations required.
  • Practical experience with large scale distributed control systems required.
  • Relevant experience in a Validation role in the biopharmaceutical industry or its equivalent.
  • Mastery of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment.
  • Comprehensive DCS and PLC based experience in the pharmaceutical industry.
  • Knowledge of procedural batch processing automation in a Delta V environment.
  • Knowledge of system life cycle validation techniques for automation software specification and development.
  • Familiar with construction techniques and automation system hardware installation practices.
  • Experience working with recognized large automation providers (Emerson, Rockwell preferred).
  • Familiarity with distributed control systems and automation (GAMP) validation concepts allows this individual to participate in cross-functional validation efforts. A working understanding of lean principles is suggested.
  • Demonstrated proficiency in project management, oral communication, and technical writing skills are required.
  • The successful candidate will possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management.
  • Work both independently and in a team environment at all levels of the organization, in particular Quality, Engineering and Manufacturing Operations.
  • Work within all Site Facilities, which requires one to give a high attention to detail and on occasion to properly use Personal Protective Equipment (PPE).

Project Description:
  • Leads the validation efforts associated with the operation of all GMP manufacturing systems (Process Automation System, Manufacturing Execution System(MES)) in a highly automated biologics manufacturing facility.
  • Manage test protocol generation, execution, issue resolution and summary report approval of required configuration changes to the site Process Automation System (Delta V).
  • Manage test protocol generation, execution, issue resolution and summary report approval of required configuration changes to the site Manufacturing Execution System (Syncade).
  • Executes and/or leads validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation programs.
  • Develops appropriate validation methodologies in collaboration with Operations management and Quality Assurance for novel projects.
  • Leads a portfolio of validation projects under strict deadlines to ensure stakeholder success and bulk drug supply.
  • Executes and/or leads multiple projects and technical work assignments as a point of contact for project stakeholders.
  • Provides validation subject matter expertise (SME), to multi-function teams, advises operations on validation matters, and defends their work before regulatory agencies.
  • Ensures alignment with the Client's directives and industry guidelines on validation.
  • Duties may include internal compliance or efficiency improvement efforts within the department.
  • Exercises sound judgment in making decisions and recommendations within generally defined practices and policies without management review.
  • May make decisions and take action on standard cases without management review.
  • May work on assignments that are extremely complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
  • Acts as an advisor to subordinates and becomes actively involved as required to meet schedules or resolve problems.
  • Erroneous decisions or failure to achieve results may have significant financial implications or cause significant delays in schedules.
  • Incumbent performs all tasks completely independently, determining methods and procedures on new assignments.
  • Receives assignments in the form of objectives and establishes goals to meet objectives. Completes projects and unusual or complex assignments with only general review from manager.
  • Identifies and reports any discrepancies from normal practices or procedures to management, recommending and implementing corrective actions, when consensus cannot be reached.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Cheryl: cambrose@alphaconsulting.Com


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Cheryl Ambrose

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