Validation Engineer

• Tech savvy person- hands on person, not afraid to learn or use computerized systems and equipment. Proficient in word, excel, and PowerPoint.
• Basic knowledge GMP and basic understanding of validation and pharma guidelines. New grads would be considered.
• Prefer those with science or engineering degrees.

• Ability to train quickly – not shy to ask questions or ask people to do things. We only have a short amount of time.
• Ability to juggle multiple priorities.
• Ability to properly communicate. Good use of common word applications. Speak up when there is an issue and ability to contribute to solutions rather than waiting.

• Most likely will be the manager and another peer interviewer

• 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 re-validations 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.

• 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.
• Able to prioritize workload and tasks. Ability to follow good project management practices to meet schedules while ensuring compliance with procedures and regulations.

• 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.

• BS Degree in Science, Engineering or Math with at least one or more years of experience.

• 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.

Triunity Software