Validation Engineer 2 Openings

Description
Summary:
Must not be allergic to Cephalosporins or Penicillin.
This position is responsible for the development and the execution of projects which include engineering studies validation protocols and revalidations of manufacturing facilities equipment utilities computerized systems cleaning methods and processes. Validation activities include research protocol writing/execution and final report generation. Additionally investigations of manufacturing challenges are conducted and process improvements are evaluated/implemented. Final documents are archived and may be included in or support A/NDA submissions and made available as needed during
FDA and client/customer compliance audits.

Essential Duties and 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 followup 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 nonconformance event records as required.
Serves as a project lead for projects of intermediate scope with crossfunctional teams.
Able to prioritize workload and tasks. Ability to follow good project management practices to meet schedules while ensuring compliance with procedures and regulations.

Qualifications:
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.

Education and/or Experience:
BS Degree in Science Engineering or Math with at least one or more years of experience.

Manager Notes:
What type of pharma validation will the worker be doing Water Filtration / Cleaning Validation / Product Validation / Lab Equipment validation or Manufacturing Equipment validation
General validation activities specifically laboratory equipment and manufacturing equipment validation.
How many years of validation experience would you like this candidates to possess at a minimum
1 year is preferred in validation. At least two years in pharma industry would be required. We need to ensure we have someone that does not require sponsorship now or in the future. Although this is not explicitly contract to hire if the conditions permit this would be someone we would like to hire permanently.
Does the worker need to work onsite or can they work remotely
The worker must be on site.