Senior CQV / Senior Validation Engineer 2

Company:  Verista
Location: Germantown
Closing Date: 25/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description

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 expertiseSenior CQV Engineer Responsibilities:Managing the responsibilities on multiple simultaneous projects and/or clientsDriving the activities as client facing leader and responsible partyAct as the defined point of escalation and issue management on client projectsDesigning validation plansDesigning and executing engineering studies for critical process parameter definition and verification prior to validationVerifying system drawings including ability to review and as built P&IDs (piping and instrumentation drawings) and I&C (instrumentation and controls) drawings as well as verifying electrical schematics with support of an electrical engineerConducting and documenting impact and risk assessments with a full understanding of equipment/system/ software operation and ability to assess direct, indirect, and no impact systems and functions within complex processesFluent in working with equipment OEMs and installation vendorsMaintaining (and ensuring the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance auditsAuthoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leaderRunning test scripts and documenting resultsAdherence with project schedule for all assigned activitiesMaintaining clear, detailed records qualification and validationDocumenting impact and risk assessments as part of a teamCompleting user interface testing, software verification, and complete alarm testing on automated systemsDeveloping, reviewing, and executing testing documentationMaking recommendations for design or process modification based on test results when executing test scriptsGeneral understanding of capital equipment implementation and process knowledgeUnderstanding validation documents, URS, IQ, OQ, PQRequirementsDemonstrated experience in Commissioning & Validation activities covering URS (GMP equipment)Demonstrated experience authoring and executing FAT, SAT, IOQ, CSV ProtocolsSpecific experience with 6 reactors (2,000gal+)/receivers, Filter Dryers, Centrifuges, Core Dryers, Powder handling systems, clean rooms, support facilities and tank farms preferredMust be willing to work onsite in Germantown, WI5-7 years of demonstrated CQV experience in GMP regulated environmentsObvious business maturity and interpersonal skills to be able to effectively communicate and collaborateExperience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client’s organizationProven attention to detail and organization in project workCapable of working on assigned tasks without mentorshipGMP and Good Documentation Practice training (may be completed at onboarding)Intermediate 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 capabilitiesBenefitsWhy 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 BereavementFor more information about our company, please visit us at Verista.com ( 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.$107,800 - $129,826*Verista is an equal opportunity employer.

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