Validation Engineer / CSV (computer system validation)

Synkriom
Devens, MA
22 Apr 2024

Vacancy expired!

Title: Validation Engineer

Location: Devens, MA 01434

(Hybrid)

Job type: 7+ months Contract

Client:

Direct Client

Qualifications:• Specific technical skills with biopharmaceutical processing including a minimum of 5 years of experience developing and/or testing process automation system software (preferably Delta V batch). Understanding of S88 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, preferably gained in the pharmaceutical industry.• Knowledge of procedural batch processing automation in a Delta V environment.• Knowledge of a system life cycle validation techniques for automation software specification and development.• Familiar with construction techniques and automation system hardware installation practices.• Experience with dealing 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 a 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.

Education:Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical preferred), a related discipline. 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).

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Regards,

Mark | Sr IT RecruiterSynkriom Inc |30 Knightsbridge Road, Suite 525, Piscataway, New Jersey, 08854

Office: |

Fax:

732–384-3301 |

Email:

Web:

  • ID: #49750260
  • State: Massachusetts Devens 01434 Devens USA
  • City: Devens
  • Salary: Depends on Experience
  • Job type: Contract
  • Showed: 2023-04-22
  • Deadline: 2023-06-20
  • Category: Et cetera