Job Description:
With direct supervision, responsible for generating and editing regulatory and customer compliant documents for Environmental Control Systems (Bldg. Mgmt System) applied to Life Sciences project.

In order to develop accurate documentation, the position requires understanding of HVAC systems, Electrical Ladder diagrams, control logic, and the ability to read and interpret Mechanical drawings including Air Flow and Process Piping diagrams. (Training will be provided.)

Provide support to Validation Engineers.

Edit validation documents as required.

Follow defined document management procedures for document development, editing, review, approval, and filing.

Follow specific customer requests for document format and content.

Create validation documents from standard templates.

Work directly with Subject Matter Experts and Validation Engineers to ensure technical accuracy of all documents.

Interpret validation scope worksheets, and apply this to project deliverables.

Provide peer reviews with respect to compliance with document format and standards.

REQUIREMENTS:
Two or Four-year degree in technical field and two years experience within a regulatory compliant environment. M.E. or E.E. preferred.

D. EXPERIENCE:
Some understanding of Pharmaceutical processes and plant design, cGMP and other regulatory agency principles, documentation practices and validation requirements.

E. INTERPERSONAL SKILLS:
Good oral and written communication skills.

Good personal computer skills.

Ability to work independently.