Validation Engineer

Responsibilities:

Be involved in design of experiments, development of new methodologies and improving existing methodologies, data generation, report development and presentation.

Schedule, plan, communicate, and manage documents and follow-up on validation activities. Interpret and apply regulatory requirements concerning validation activities.

Applies knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.

Perform validation activities to lead and/or support cleaning, equipment, computer systems, utility, facility, and method validations

Review and generate quality documents including validation protocols, SOPs, change controls, and non-conformance event records as required.

Serves as a project lead for projects of intermediate scope with cross-functional teams.

Requirements:

Direct experience with writing and executing validation protocols is preferred.

Understand scientific strategies and be able to invent new methods or new avenues of investigation.

Good interpersonal/communication/influencing/negotiation skills.

Strong project management skills

Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.

Proficient in Microsoft Word and Excel, computer software. Some experience with statistical software helpful.

Direct or indirect industry knowledge.

Ability to work independently or in teams.

Physical demands of the position may require the ability to lift materials up to 20 lbs., dexterity to gown, mobility to maneuver around equipment, and enter into confined spaces.