Verista
Validation Lead (Labs) / Lead Validation Engineer/Analyst
Verista, Winchester, Massachusetts, us, 01890
Verista's
600 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:We empower and support our colleaguesWe commit to client success at every turnWe have the courage to do the right thingWe encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.We constantly acquire new skills and learn from our experiences to enhance our collective expertiseValidation Lead (Laboratory) Analyst Responsibilities:
Perform validation activities including generation of trace matrices and summary reports for the following instruments:MTS Tensile Tester with associated computerDS TOC AnalyzerLAL Test Equipment-Pyros Kinetix Flex Tube Reader w/softwareEvolution Bio 260 spectrophotometerOlympus CIX-100 Imaging Microscope w/ softwareMoisture Analyzer (includes method transfer / qual)Generation of URSReview and execution of Vendor protocolsGeneration and execution of wrapper protocols (IQ, OQ, PQ) CSV and DI protocols (as needed)Create Requirement documents from vendor manualsPerform method transfersIndependently lead the Client through the Validation Lifecycle required for their identified equipmentRequirements
Must be willing to work in a hybrid capacity with onsite work required in Woburn, MA a large percentage of the timeBachelor's degree in Engineering, Life Sciences, or a related fieldDemonstrated experience in executing laboratory instrument validation activitiesExpertise in Data Integrity10+ years of role relevant experienceStrong understanding of FDA regulations and cGMP requirementsCapability to lead a Validation effort, from identification of applicable tests and requirements of an instrument to closure of all testing activities.Excellent documentation and communication skillsProficiency using PC and Microsoft Office toolsOutgoing personality with strong ability to communicate effectively with peers in clear, concise termsAbility to work as part of a teamStrong problem-solving and critical thinking skillsExcellent organizational and time management skillsStrong attention to detailGMP and Good Documentation PracticeIntermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)Basic skills with EXCEL and PowerPointStrong interpersonal skills and clear communication capabilitiesExperience with and tolerance for high levels of challenge and changeProven attention to detail and organization in project workCapable of working on assigned tasks without mentorshipBenefits
Why Choose Verista?
High growth potential and fast-paced organization with a people-focused cultureCompetitive pay plus performance-based incentive programsCompany-paid Life, Short-Term, and Long-Term Disability Insurance.Medical, Dental & Vision insurancesFSA, DCARE, Commuter BenefitsSupplemental Life, Hospital, Critical Illness and Legal InsuranceHealth Savings Account401(k) Retirement Plan (Employer Matching benefit)Paid Time Off (Rollover Option) and HolidaysAs Needed Sick TimeTuition ReimbursementTeam Social Activities (We have fun!)Employee RecognitionEmployee Referral ProgramPaid Parental Leave and Bereavement
For more information about our company, please visit us at Verista.com
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
$87,780 - $129,826
*Verista is an equal opportunity employer.
600 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:We empower and support our colleaguesWe commit to client success at every turnWe have the courage to do the right thingWe encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.We constantly acquire new skills and learn from our experiences to enhance our collective expertiseValidation Lead (Laboratory) Analyst Responsibilities:
Perform validation activities including generation of trace matrices and summary reports for the following instruments:MTS Tensile Tester with associated computerDS TOC AnalyzerLAL Test Equipment-Pyros Kinetix Flex Tube Reader w/softwareEvolution Bio 260 spectrophotometerOlympus CIX-100 Imaging Microscope w/ softwareMoisture Analyzer (includes method transfer / qual)Generation of URSReview and execution of Vendor protocolsGeneration and execution of wrapper protocols (IQ, OQ, PQ) CSV and DI protocols (as needed)Create Requirement documents from vendor manualsPerform method transfersIndependently lead the Client through the Validation Lifecycle required for their identified equipmentRequirements
Must be willing to work in a hybrid capacity with onsite work required in Woburn, MA a large percentage of the timeBachelor's degree in Engineering, Life Sciences, or a related fieldDemonstrated experience in executing laboratory instrument validation activitiesExpertise in Data Integrity10+ years of role relevant experienceStrong understanding of FDA regulations and cGMP requirementsCapability to lead a Validation effort, from identification of applicable tests and requirements of an instrument to closure of all testing activities.Excellent documentation and communication skillsProficiency using PC and Microsoft Office toolsOutgoing personality with strong ability to communicate effectively with peers in clear, concise termsAbility to work as part of a teamStrong problem-solving and critical thinking skillsExcellent organizational and time management skillsStrong attention to detailGMP and Good Documentation PracticeIntermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)Basic skills with EXCEL and PowerPointStrong interpersonal skills and clear communication capabilitiesExperience with and tolerance for high levels of challenge and changeProven attention to detail and organization in project workCapable of working on assigned tasks without mentorshipBenefits
Why Choose Verista?
High growth potential and fast-paced organization with a people-focused cultureCompetitive pay plus performance-based incentive programsCompany-paid Life, Short-Term, and Long-Term Disability Insurance.Medical, Dental & Vision insurancesFSA, DCARE, Commuter BenefitsSupplemental Life, Hospital, Critical Illness and Legal InsuranceHealth Savings Account401(k) Retirement Plan (Employer Matching benefit)Paid Time Off (Rollover Option) and HolidaysAs Needed Sick TimeTuition ReimbursementTeam Social Activities (We have fun!)Employee RecognitionEmployee Referral ProgramPaid Parental Leave and Bereavement
For more information about our company, please visit us at Verista.com
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
$87,780 - $129,826
*Verista is an equal opportunity employer.