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Senior Validation Engineer (cGMP - Pharmaceutical)

DPS Boston, MA Full-Time
$88,253.00 (Careerbuilder est.) What is the Careerbuilder Estimated Salary? Only about 20% of the jobs in our search results contain salary information. When a job posting doesn’t include a salary, we estimate it by looking at similar jobs in the same industry in that location. It is not necessarily endorsed by the employer and actual compensation may vary based on your experience.
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Senior Validation Engineer (cGMP - Pharmaceutical)       JD817624

Boston, MA area


Summary:


DPS Engineering is looking for a Senior Validation Engineer to work with a BioPharma client in the Boston, MA area. This individual will be responsible for the validation of biologics equipment and be expected to take a leadership role managing daily activities of qualification/validation and continuous improvement projects. Projects will involve engineering changes to existing equipment and processes, introduction of new manufacturing processes, support of existing manufacturing processes, continuous improvement of engineering processes and support of other groups within the Engineering department.


Responsibilities:

  • Design validation protocols, perform/coordinate validation testing, and analyze/assemble results to create a finished validation test protocol as required.
  • Perform validation activities, prepare protocols, and complete documentation necessary to support production activities.
  • Review and approve documentation as assigned as well as new equipment specifications.
  • Must be able to write and execute validation plans, protocols and reports for process equipment changes per existing procedures and templates, and will be required to create validation plans and protocols for non-routine equipment or test needs
  • Mentor and guide junior engineers and engineering technicians in the development and execution of equipment change control plans and qualification/validation test protocols.
  • Advise other departments on SOPs related to validation projects.
  • Execute assigned jobs and tasks according to schedule prepared by Engineering Planning.
  • Complete other special projects and assignments as required.
  • Comply with all regulatory, corporate, and site quality system procedures, especially safety and cGMPs.

Qualifications:

  • BS/MS in chemical or mechanical engineering or relevant discipline.
  • Minimum of 5+ years of experience working within biologics/biotech production environment.
  • Must have a working knowledge of cGMP type systems and practices.
  • Working knowledge of bioreactors, sanitary equipment, piping, process instrumentation and controls is required.
  • Expertise in Clean-In-Place and Steam-In-Place theory and techniques is required.
  • Experience with cleaning validation is preferred.
  • Experience with temperature mapping of environmental chambers, autoclave validation and qualification of freezing procedures is strongly desired.
  • Familiarity with distributed control systems (DCS) and process logic controllers (PLC) is required.
  • Strong technical writing and documentation skills are required.
  • Must be able to work independently with adequate supervision, multi-task and support several projects simultaneously.
  • Must demonstrate strong interpersonal and teamwork skills.

Recommended skills

System Procedures
Programmable Logic Controllers
Scheduling
Distributed Control Systems
Reports
Instrumentation

Location

CareerBuilder Estimated Salary What is the Careerbuilder Estimated Salary? Only about 20% of the jobs in our search results contain salary information. When a job posting doesn’t include a salary, we estimate it by looking at similar jobs in the same industry in that location. It is not necessarily endorsed by the employer and actual compensation may vary based on your experience.

x

What is the Careerbuilder Estimated Salary?

Only about 20% of the jobs in our search results contain salary information. When a job posting doesn’t include a salary, we estimate it by looking at similar jobs in the same industry in that location. It is not necessarily endorsed by the employer and actual compensation may vary based on your experience.
This estimation is based on Job title, Industry, Location and Skills
$88,253
Avg. Yearly Salary
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Job ID: JD817624

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