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Syracuse

    Lead CQV Engineer/Analyst - Syracuse, United States - Verista

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    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 colleagues
    • We commit to client success at every turn
    • We have the courage to do the right thing
    • We 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 expertise

    Lead CQV Engineer Responsibilities:

    • Role will drive the CQV strategy for the project, leading a team of engineers to successfully deliver deliverables
    • Author, edit, and execute technical commissioning, qualification and validation documentation for standard equipment/systems/ software
    • Adherence with project schedule for all assigned activities
    • Maintaining clear, detailed records for qualification and validation
    • Documenting impact and risk assessments as part of a team
    • Making recommendations for design or process modification based on test results when executing test scripts
    • General understanding of capital equipment implementation and process knowledge
    • Understanding validation documentation from URS to Summary Reporting

    Requirements

    • Must be willing to work onsite in Syracuse, NY
    • Minimum of 12 years of experience in CQV activities specific to a broad range of facility, utility, and process equipment including autoclaves, fillers, reactors, isolators, freezers, etc
    • Extensive experience authoring and executing IQ/OQ/PQ activities
    • Ability to write sampling protocols and develop protocol templates
    • Specific qualification experience with Autoclaves, TFF Skid, chrom skid (preferred)
    • Experience qualifying Single User Reactors and Single Use Mixers (preferred)
    • Experience developing and executing mixing studies
    • Experience with cleanroom developing and/or executing EMPQ protocols
    • Knowledge of Process Automation and equipment testing
    • Experience using Delta V
    • Bachelor's degree (minimum) in hard sciences, preferably Chemical Engineering
    • Proficiency in using PC and Microsoft Office tools
    • Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
    • Ability to lead a team of engineers
    • Strong problem-solving and critical thinking skills
    • Excellent organizational and time management skills
    • Strong attention to detail
    • GMP and Good Documentation Practice knowledge
    • Strong interpersonal skills and clear communication capabilities
    • Experience with and tolerance for high levels of challenge and change
    • Proven attention to detail and organization in project work
    • Capable of working on assigned tasks without mentorship

    Benefits

    Why Choose Verista?
    • High growth potential and fast-paced organization with a people-focused culture
    • Competitive pay plus performance-based incentive programs
    • Company-paid Life, Short-Term, and Long-Term Disability Insurance
    • Medical, Dental & Vision insurances
    • FSA, DCARE, Commuter Benefits
    • Supplemental Life, Hospital, Critical Illness and Legal Insurance
    • Health Savings Account
    • 401(k) Retirement Plan (Employer Matching benefit)
    • Paid Time Off (Rollover Option) and Holidays
    • As Needed Sick Time
    • Tuition Reimbursement
    • Team Social Activities (We have fun)
    • Employee Recognition
    • Employee Referral Program
    • Paid Parental Leave and Bereavement

    For more information about our company, please visit us at

    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 - $151,463

    • Verista is an equal opportunity employer


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