Non-IT

Validation Engineer

Contract

Medasource

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Position: Validation Engineer

Location: Worcester, MA

Start Date: ASAP

Duration: 6 month contract with extension

Job Description

The Validation Engineer will be responsible for commissioning and qualification activities associated with capital projects involving the installation and/or renovation of biopharmaceutical process equipment, facilities, and utilities in an FDA/GMP regulated environment. The engineer will work in a multi-disciplinary team environment.

Qualifications:

  • B.S. in engineering or technical discipline, or equivalent experience, with a minimum of 2+ years of experience supporting biologics manufacturing through validation of biologics equipment or processes
  • An understanding of basic unit operations involving cell culture and protein purification is desired
  • Working knowledge of bioreactors, sanitary equipment, hygienic piping, process instrumentation and controls is required
  • Expertise in Clean-In-Place and Steam-In-Place theory and techniques is preferred
  • Experience with risk- based approach to commissioning and qualification preferred
  • Experience with temperature mapping of environmental chambers, autoclave validation is strongly required
  • Familiarity with distributed control systems and process logic controllers is required
  • Must have familiarity with P&IDs, loop diagrams, etc.
  • Must have hands-on experience on the Kaye Validator
  • Familiarity with project management is preferred
  • Experience with risk assessment and system classification is a plus
  • Adherence to cGMP and GDP is required
  • Strong technical writing skill is required
  • Strong organizational, prioritization, technical, mechanical, and communication skills as well as experience in a GMP environment are preferred
  • Must be able to work independently with adequate supervision, multi-task and support several projects simultaneously
  • Must demonstrate strong interpersonal & teamwork skills

Responsibilities:

  • Prepare validation test protocols, set validation strategy, perform/coordinate validation testing for capital projects of different complexity in concert with all stakeholders, and analyze/assemble test results to create summary reports as required
  • Review new equipment specifications (IQ)
  • Work with appropriate departments and personnel to resolve validation testing issues
  • Advise other departments on SOPs related to validation projects
  • Maintain 100% on time training
  • Execute assigned jobs and tasks according to schedule
  • Achieve Site, Department and Group performance metrics
  • Complete other special projects and assignments as required
  • Comply with all regulatory, corporate, and site quality system procedures, especially safety and cGMPs

Significant Work Activities and Conditions:

  • Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
  • Continuous standing/walking for prolonged periods (more than 2 consecutive hours in an 8 hour day)
  •  Work in a manufacturing environment with: awkward/forceful/repetitive (arms above shoulder, bent wrists) use of arms
  • Work in a clean room environment
  • Lift, carry, push or pull weights of more than 20 pounds on a regular basis
  • Routine work with chemicals
  • Wear ear plugs
  • Work at heights, e.g. ladders, scaffolds, catwalks, etc.
  • Work requiring repeated bending, stooping, squatting or kneeling

Medasource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.

JO-2106-112227

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