What are you top three to five technical skills requirements?
• 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.
What are your top three to five soft skill wants?
• 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.
What is the expected interview process?
• Most likely will be the manager and another peer interviewer
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 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.
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 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.
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.
Compensation: $60,000.00 - $90,000.00 per year
About Us
Triunity is a Product Development, Staff Augmentation, and Consulting Services company providing solutions and services in North America. We provide IT services and technology solutions to various business verticals like Healthcare, Pharma, Banking, Finance, etc. Our goal is to develop a long-term partnership with businesses and help them get a competitive advantage by providing IT infrastructure and software platforms.
Lead by experts in the IT industry with a proven record of delivering software solutions, consulting, and staffing services, we have expertise in fulfilling client needs in terms of customized business solutions as well as IT consulting. At Triunity, we always try to bring the right mix of skills, technologies, and experts together which helps our clients to stay ahead in the competition. Our goal is to make our clients empower with cutting-edge technologies and take care of all their IT needs so they can focus more on their core business.
Triunity Culture
Our core value is our people and our teams . We believe the real mantra of success is like minded people with right mix of technical and analytical skills. Our strength lies in bringing right set of people and delivering work as a team. Be it expert or intern Triunity always always value its own people and give them platform to excel in their career.
At Triunity you can expect
- Challenging & Friendly
- Work on new edge technologies & tools
- Work with industry experts
- Solving complex client problems and delivering solutions
- Working on projects lasting from six months to several years
At Triunity people are motivated by the complexity and challenges they face when working on client projects . We always motivate our people to keep learning new technologies and also give them platform where they can get chance to show their technical and analytical skills . We help our people in adding latest technologies ,tools, methodologies and certifications to their resume by arranging trainings , seminars and knowledge sharing sessions.