Evergen
Job Description
Location:
This is an onsite role based in Alachua, FL. RTI Surgical is now Evergen! This rebranding reflects our strategic evolution as a leading CDMO in regenerative medicine and comes at the end of a significant year for the business, including the successful acquisitions of Cook Biotech in IN. and Collagen Solutions, MN. Our new brand identity emphasizes our unique positioning as the only CDMO offering a comprehensive portfolio of allograft and xenograft biomaterials at scale. Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ. Read more about this change and Evergen’s commitment to advancing regenerative medicine here: https://lnkd.in/eMSfVJkM RESPONSIBILITIES Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology Develop 21 CFR Part 11 computer system validation plans, qualification test protocols, traceability matrices, reports, IQ/OQ/PQ protocols, and all other documents within the scope of the validation plan Develop and maintain test plans, test scripts, user acceptance tests, and manage the execution of test plans Maintain and improve software validation and testing processes Work with software developers and testers to write specification documents according to established procedures Design and set up product labels using Loftware, SQL, and ZPL based on requirements from stakeholders Conduct validation and testing for product labels Set up meetings with key project stakeholders to gather requirements for software development projects Conduct analysis of business processes and functional requirements Apply technical and business knowledge to analyze stakeholder requirements and document as part of the software validation process Work with cross-functional leadership and functional teams to understand business requirements and investigate issues using root cause analysis for NCs, CAPAs, and projects Other duties as assigned REQUIREMENTS: Education Associate degree in computer science, information technology, or related field Experience 0-3 years of relevant experience in a regulated industry in testing, quality assurance, or validation documentation development using risk-based methodology Additional experience may be substituted for education requirements Experience with Manufacturing, ERP, quality systems, database systems, SQL is preferred Experience in Agile software development lifecycle processes is preferred Experience in regulated environments, such as FDA or AATB, is preferred Skills Excellent verbal and written communication Computer Systems Validation (CSV) methodologies using a risk-based approach Experience with Octane for manual and automated testing Advance SQL query writing Excellent problem-solving skills with ability to work in collaborative and independent working situations and environments with minimal supervision Must work and interact effectively and professionally with and for others throughout various levels of the global organization Ability to simultaneously manage multiple projects Ability to remain calm and receptive in fast-paced situations Travel Occasional travel for training and meetings as needed. Safety: Physical Requirement Move or lift objects up to 25 pounds Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays Frequent (>75% fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.) Working Environment Onsite: Office environment with assigned workstation More about Evergen: Evergen provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management. Evergen is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values: Accountable:
We own our actions and decisions. Agile:
We embrace change to stay ahead of the curve and evolve to drive innovation and growth. Growth Mindset:
We embrace challenges as opportunities for continuous learning. Customer-Centric:
We prioritize customers at every touch point. Inclusive:
We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated. At Evergen, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success. Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential. #LI-onsite
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Location:
This is an onsite role based in Alachua, FL. RTI Surgical is now Evergen! This rebranding reflects our strategic evolution as a leading CDMO in regenerative medicine and comes at the end of a significant year for the business, including the successful acquisitions of Cook Biotech in IN. and Collagen Solutions, MN. Our new brand identity emphasizes our unique positioning as the only CDMO offering a comprehensive portfolio of allograft and xenograft biomaterials at scale. Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ. Read more about this change and Evergen’s commitment to advancing regenerative medicine here: https://lnkd.in/eMSfVJkM RESPONSIBILITIES Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology Develop 21 CFR Part 11 computer system validation plans, qualification test protocols, traceability matrices, reports, IQ/OQ/PQ protocols, and all other documents within the scope of the validation plan Develop and maintain test plans, test scripts, user acceptance tests, and manage the execution of test plans Maintain and improve software validation and testing processes Work with software developers and testers to write specification documents according to established procedures Design and set up product labels using Loftware, SQL, and ZPL based on requirements from stakeholders Conduct validation and testing for product labels Set up meetings with key project stakeholders to gather requirements for software development projects Conduct analysis of business processes and functional requirements Apply technical and business knowledge to analyze stakeholder requirements and document as part of the software validation process Work with cross-functional leadership and functional teams to understand business requirements and investigate issues using root cause analysis for NCs, CAPAs, and projects Other duties as assigned REQUIREMENTS: Education Associate degree in computer science, information technology, or related field Experience 0-3 years of relevant experience in a regulated industry in testing, quality assurance, or validation documentation development using risk-based methodology Additional experience may be substituted for education requirements Experience with Manufacturing, ERP, quality systems, database systems, SQL is preferred Experience in Agile software development lifecycle processes is preferred Experience in regulated environments, such as FDA or AATB, is preferred Skills Excellent verbal and written communication Computer Systems Validation (CSV) methodologies using a risk-based approach Experience with Octane for manual and automated testing Advance SQL query writing Excellent problem-solving skills with ability to work in collaborative and independent working situations and environments with minimal supervision Must work and interact effectively and professionally with and for others throughout various levels of the global organization Ability to simultaneously manage multiple projects Ability to remain calm and receptive in fast-paced situations Travel Occasional travel for training and meetings as needed. Safety: Physical Requirement Move or lift objects up to 25 pounds Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays Frequent (>75% fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.) Working Environment Onsite: Office environment with assigned workstation More about Evergen: Evergen provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management. Evergen is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values: Accountable:
We own our actions and decisions. Agile:
We embrace change to stay ahead of the curve and evolve to drive innovation and growth. Growth Mindset:
We embrace challenges as opportunities for continuous learning. Customer-Centric:
We prioritize customers at every touch point. Inclusive:
We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated. At Evergen, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success. Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential. #LI-onsite
#J-18808-Ljbffr