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5896 - Senior Process Engineer 2 / Senior CQV Engineer

Verista - Novato, CA

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Job Description

Join to apply for the 5896 - Senior Process Engineer 2 / Senior CQV Engineer role at Verista.Verista’s 500 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 pany culture guidelines & valuesWe 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 expertiseResponsibilitiesMeet with client stakeholders and SMEs to develop Process Validation (PV) protocols in preparation for and throughout Process Performance Qualification (PPQ)Coordinate execution of PV protocols, including sampling, testing, data tracking, and data collection with various internal functional groups and external contract labsSummarize execution of PV protocols in final reports and prepare final packages for SME review and approvalManage the responsibilities on multiple simultaneous projects and/or clientsDrive the activities as client facing leader and responsible partyAct as the defined point of escalation and issue management on client projectsQualificationsAbility to take independent leadership role on project(s)Coordination and direction of process validation activities involving cross functional teams including Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and othersSome trips to Novato, CA site 1 or 2 x a year may be necessary to oversee executionProven ability to identify areas of business expansion and initiate technical discussion on Verista solutions for business expansionDemonstrated project leadership capabilitiesDemonstrated experience with various stages of clinical and commercial manufacturing in a Quality and/or Process Sciences RoleStrong understanding of process fundamentals and qualification/validation requirements for the following:Small molecule chemical synthesisMonoclonal antibody or protein biomanufacturingCell therapy and regenerative medicineSterile drug product fill/finish Analytical QC laboratoriesComputer SystemPackagingAbility to architect Process implementations and execute against complex project tasks.Advanced Microsoft Project capabilitiesSalary and benefitsThe salary range for the US is variable by location and other factors; actual compensation will be determined by the company.Verista is an equal opportunity employerHigh 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 InsuranceMedical, 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 BereavementSeniority levelMid-Senior levelEmployment typeFull-timeJob functionManagement and ManufacturingIndustriesPharmaceutical Manufacturing #J-18808-Ljbffr

Created: 2025-09-17

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