Senior CSV Engineer (Polarion) / Senior Validation Engineer 2

Company:  Verista
Location: Cambridge
Closing Date: 26/10/2024
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 CSV Engineer Responsibilities:Our team needs a senior level CSV Engineer with ALM experience, ideally with Polarion. Experience with ALM tools such as Kneat, Valgenesis may be considered in lieu of Polarion experience. This person should have strong lab informatics (LIMS, data archive, ELN, etc.), good/deep LabVantage experience, and be well versed in CSA methodology and be able to handle projects (from a technical and validation perspective) such as:Calculation validations in LabVantageInstrument integration with LabVantageJMP/Statistica integration with LabVantageData migration from legacy stability system into LV and legacy system decommissioningIntegration of Sarepta LIMS with CMO LIMSSplashlakeRequirements• A minimum of a Bachelor’s degree in an Engineering or Scientific degree and 6-10 years of role relevant experience• Demonstrated experience working with Polarion highly preferred, MUST have significant experience using ALM software• Strong Lab Informatics experience• Direct experience with LIMS (LabVantage)• Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate• Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client’s organization• Proven attention to detail and organization in project work• Capable of working on assigned tasks without mentorship• Experience authoring/editing/executing validation documents for laboratory equipment• Working knowledge of FDA regulations, ISPE guidelines and ISO standards including:Good Documentation Practice (GDP) in pharmaceutical environment21 CFR Part 11BenefitsWhy 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.$80,465-121,170*Verista is an equal opportunity employer.

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