Full-Time
Senior C&Q Engineer / Senior Validation Engineer
Verista
201-500 employees
GxP lifecycle consulting for life sciences
Compensation Overview
$78.9k - $113.5k/yr
Devens, MA, USA
Remote
Remote within the United States, with limited travel to client sites as requested.
Bachelor's
 Biology & Biotech (1) |
|---|
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- A bachelor's degree in Engineering, Life Sciences, or another industry-related technical discipline.
- At least 5 years of experience in commissioning and qualification, commissioning, qualification, validation, engineering, or technical project execution within regulated pharmaceutical, biotechnology, or life sciences environments.
- Hands-on experience commissioning and qualifying GMP facilities, utilities, equipment, manufacturing systems, or laboratory systems.
- Strong working knowledge of commissioning and qualification methodologies and deliverables, including user requirements specifications, design qualification, factory acceptance testing/site acceptance testing, commissioning, installation/operational/performance qualification, traceability, risk assessments, deviations, and qualification summary reports.
- Working knowledge of Good Manufacturing Practices, Good Engineering Practice, ASTM E2500, risk-based qualification, and Good Documentation Practices.
- Experience authoring, reviewing, and executing commissioning and qualification protocols, test scripts, commissioning documents, qualification reports, standard operating procedures, work instructions, and other controlled documentation.
- Experience coordinating field execution with Engineering, Quality, Operations, Automation, Maintenance, vendors, and other cross-functional stakeholders.
- Familiarity with punch-list management, discrepancy and deviation resolution, change control, turnover, system handoff, and commissioning and qualification closeout activities.
- Strong understanding of requirements traceability, test evidence, documentation workflows, and qualification lifecycle management.
- Strong written and verbal communication, organizational, problem-solving, and stakeholder-management skills.
- Ability to manage multiple priorities and work independently within a global, cross-functional project environment.
- Lead and support commissioning and qualification activities for GMP facilities, utilities, equipment, and manufacturing systems throughout the project lifecycle.
- Develop, review, and execute commissioning and qualification deliverables, including user requirements specifications, risk assessments, design qualification, factory acceptance testing/site acceptance testing, commissioning test plans, installation/operational/performance qualification protocols, traceability matrices, and qualification summary reports.
- Coordinate commissioning and qualification execution activities, including protocol scheduling, field execution, test evidence collection, punch-list management, discrepancy and deviation resolution, retesting, and final documentation closeout.
- Support the development and implementation of risk-based qualification strategies in accordance with Good Manufacturing Practices, ASTM E2500, Good Engineering Practice, and applicable site and client procedures.
- Author, review, and update commissioning and qualification procedures, protocols, work instructions, commissioning documents, test scripts, templates, and qualification reports in accordance with Good Documentation Practices.
- Manage commissioning and qualification documentation through electronic document management and digital qualification platforms, ensuring proper formatting, metadata, traceability, approvals, and document lifecycle control.
- Support digital commissioning and qualification execution and documentation, including configuration and use of Kneat or similar platforms, electronic protocols, test evidence, workflows, and qualification records.
- Coordinate with Engineering, Automation, Quality, Operations, Maintenance, Facilities, Information Technology, subject matter experts, site teams, and external vendors to align commissioning and qualification activities with project schedules and operational requirements.
- Maintain commissioning and qualification project trackers covering protocol status, execution progress, open actions, punch-list items, deviations, documentation readiness, system turnover, and qualification closeout.
- Support facility and equipment turnover, commissioning completion, qualification readiness, and operational handoff to site teams.
- Provide status updates on commissioning and qualification progress, schedule, risks, issues, dependencies, and outstanding actions to project and site leadership.
- Support inspection and audit readiness by ensuring commissioning and qualification documentation is complete, traceable, technically justified, and compliant with applicable Good Manufacturing Practices requirements.
- Support multiple concurrent commissioning and qualification projects and priorities while maintaining quality, schedule, and documentation requirements across a global, cross-functional organization.
- Kneat Power User Level 1 or higher certification, with hands-on experience using Kneat or similar digital commissioning and qualification or validation platforms.
- Experience with HP ALM/Quality Center, Jira, or other project and test-management platforms.
- Experience with BMS, Documentum, Veeva Vault, or other electronic document management systems.
- Experience supporting large-scale pharmaceutical or biotechnology capital projects, facility expansions, equipment installations, or multi-site commissioning and qualification programs.
Verista provides business and technology consulting for life science companies, focusing on systems, compliance, validation and quality across the GxP lifecycle. Its services cover preclinical, clinical, commercialization, manufacturing and distribution to ensure safe, high-quality results. The company combines decades of industry knowledge with advanced engagement platforms and transformative technologies to help clients solve complex challenges with one partner across specialties. With a team of 500+ experts, Verista supports clients from strategy and validation to execution, delivering consistent, compliant outcomes that improve health and lives. The goal is to enable better health outcomes by ensuring products and processes are safe, compliant and efficient throughout the product development lifecycle.
Company Size
201-500
Company Stage
N/A
Total Funding
N/A
Headquarters
Fishers, Indiana
Founded
2020
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Simplify's Take
What believers are saying
- Verista acquired Integral Solutions on July 31, 2026, expanding engineering and validation capacity.
- INTERPHEX 2026 showcased COUNTQ and KITQ, signaling active product-led selling into packaging operations.
- The Sware partnership keeps Verista positioned for digital validation modernization and Pharma 4.0 adoption.
What critics are saying
- Carl Weiss v. Verista in ERISA court, filed February 20, 2026, signals payroll liabilities.
- Kenyon v. Verista, Inc. filed April 2, 2026, adds employment-discrimination distraction and discovery risk.
- Integrity and validation services face commoditization; larger consultancies can undercut pricing by 2027.
What makes Verista unique
- Verista combines CSV, commissioning, automation, and compliance under one regulated-life-sciences provider.
- COUNTQ and KITQ give Verista proprietary packaging inspection and reconciliation workflows.
- Michael Laferrera, appointed July 31, 2026, brings pharma-services M&A and operating discipline.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
Health Savings Account/Flexible Spending Account
401(k) Company Match
Paid Vacation
Paid Sick Leave
Paid Holidays
Paid Parental Leave
Bereavement Leave
Tuition Reimbursement
Company Social Events
Employee Referral Bonus
Commuter Benefits
Performance Bonus
Growth & Insights and Company News
6 month growth
↓ -2%1 year growth
↓ -2%2 year growth
↓ -2%Verista expands automation and validation capabilities with acquisition of Integral Solutions. 31 July 2026 Verista, a leading provider of automation, compliance, and quality solutions for the life sciences industry, announced the acquisition of Integral Solutions. Based in Columbus, OH, Integral Solutions is a life sciences business and technology services firm that specializes in engineering and validation services worldwide. The acquisition enhances Verista's capabilities in automation, engineering, project management, and validation, enabling the company to deliver further comprehensive support across the full lifecycle of regulated life sciences operations. Founded in 1997 by Lou Seich, Integral Solutions built a strong reputation for delivering high-quality engineering and validation services, grounded in a commitment to client success, a passion for employee growth, and a culture of continuous improvement. The company's team of engineering, project management, and validation professionals supported clients globally with turnkey validation solutions and complete validation lifecycle documentation. The addition of Integral Solutions reflects Verista's continued commitment to delivering best-in-class solutions and services to the pharmaceutical, biotechnology, medical device, and other regulated industries. By combining Verista's nationwide expertise in computer systems validation, commissioning and qualification, manufacturing and packaging automation, machine vision, and regulatory compliance with Integral's depth in engineering and validation, the unified organization will offer clients expanded capacity, deeper technical strength, and integrated project delivery. With the acquisition, Integral Solutions' leadership team, including founder Lou Seich, along with Amy Liddy, Robert Corn, and Wade Cole, and their respective teams, will join Verista. Their experience and long-standing client relationships will help accelerate Verista's growth while ensuring continuity of service and a smooth transition for existing customers. About Verista Verista is a leading provider of integrated end-to-end compliance, validation, and digital enablement for the Life Sciences. Headquartered in Fishers, Indiana, Verista is a one-stop partner that connects regulatory expectations with technical execution and digital transformation. Leveraging innovative technologies and over 500 industry experts, Verista empowers organizations to deliver safe, high-quality products efficiently.
Verista to showcase COUNTQ and KITQ innovations at INTERPHEX 2026. Verista, a leading provider of automation, compliance, and quality solutions for the life sciences industry, will highlight its COUNTQ and KITQ integrated offerings at INTERPHEX 2026, April 21-23 at the Jacob Javits Center in New York City, NY, at booth 4139. Underlining the company's focus on helping pharmaceutical and biotech manufacturers improve quality, reduce risk, and accelerate speed to market, these complementary solutions enable more reliable, compliant, and efficient clinical and commercial packaging operations. Verista's COUNTQ system is designed to bring a higher level of confidence and control to component counting and reconciliation processes in packaging workflows, helping manufacturers ensure that counts are accurate and documentation is consistent from batch to batch. Delivering 100% electronic verification of product counts in just 15 seconds using deep learning AI and high-resolution visual inspection with LED lighting, the system provides a processing capacity of up to 100 million vials per year and supports a standard fill line capacity of 300 vials per minute while accommodating various tray types and product sizes without tray templates for quick changeovers and unlimited recipe storage. Fully compliant with 21 CFR Part 11 regulations with a comprehensive audit trail; multiple leading injectable manufacturers, including top pharmaceutical companies and major CMOs, have implemented multiple units across their facilities, achieving improved accuracy, higher throughput, reduced labor costs, and enhanced regulatory compliance. The KITQ system provides reconciliation of complex kit designs to reduce manual effort and errors, as well as electronic management. By combining standardized kit structures with configurable workflows, KITQ provides automated accountability and complete traceability through use of tray-embedded RFID tags, automatic recipe selection, and 21CFR compliant reporting of results. The system integrates seamlessly with existing kit assembly processes and standard operating procedures, helping production managers and manufacturing engineering teams ensure that kit contents are complete, correct, and fully traceable, thereby strengthening compliance and supporting confident decision-making. Together, COUNTQ and KITQ demonstrate Verista's integrated approach to solving critical challenges at the intersection of clinical and commercial operations, giving life sciences companies a more connected view of components, kits, and packaging activities. INTERPHEX attendees are encouraged to stop by booth 4139 to meet with Verista's specialists to discuss how COUNTQ and KITQ can be tailored to their specific environments, from surgical tray setups and medical device spare part kits to large-scale commercial manufacturing. About Verista Verista is a leading provider of integrated end-to-end compliance, validation, and digital enablement for the Life Sciences. Headquartered in Fishers, Indiana, Verista is a one-stop partner that connects regulatory expectations with technical execution and digital transformation. Leveraging innovative technologies and over 500 industry experts, Verista empowers organizations to deliver safe, high-quality products efficiently.
Verista announces appointment of Michael Laferrera as Chief Executive Officer. Verista names seasoned healthcare and pharma services leader as CEO to drive strategic growth, innovation, and operational excellence. Verista, a leading provider of automation, compliance, and quality solutions for the life sciences industry, announces the appointment of Michael J. Laferrera as Chief Executive Officer, bringing to the role a dynamic and purposeful leadership style shaped by more than 35 years of proven success in the competitive healthcare industry. Laferrera is recognized for driving growth, innovation, and profitability as well as leading transformative change across both the pharmaceutical and pharma services sectors. Throughout his career, Laferrera has developed deep expertise in corporate strategy, mergers and acquisitions, organizational transformation, and stakeholder engagement, consistently aligning business vision with strong operational execution. He is known for building high-performance executive teams and fostering cultures of excellence and accountability, qualities that will support Verista's continued expansion and value creation for its clients and stakeholders. Laferrera most recently spent 17 years at Knipper Health, where he served 13 years as President and 5.5 years as Chief Executive Officer, overseeing all strategic and operational activities. Under his leadership, the company saw incredible growth through strategic acquisitions and organic expansion, increasing enterprise value. Discover more Pharmaceuticals & Biotech Consulting "We are excited to welcome Mike to Verista, where we can leverage his vast industry and leadership experience on our journey for expanded growth in 2026 and beyond," said Rich Tabarrini, President of Verista. Earlier in his career, Laferrera held a range of sales and marketing leadership positions within the pharmaceutical industry, building the commercialization and supply chain foundation that has underpinned his success on the pharma services side. Over more than three decades, he became known for leading organizations through inflection points, leveraging change management, digital innovation, and disciplined execution to deliver sustained performance improvements. As Verista's new CEO, Laferrera brings a proven track record of strategic vision, enterprise value creation, and private equity partnership, positioning the company to capitalize on new growth opportunities while strengthening operational excellence. His appointment underscores Verista's commitment to forward-thinking leadership, rigorous performance management, and a culture that rewards collaboration, accountability, and results. When asked about the appointment, Jeff Kinell, Chairman of the Verista Board of Directors, said, "We are thrilled to welcome Mike to the Verista team. He is the right leader at the right time to guide Verista on its journey to provide innovative solutions to the evolving needs of our customers. He is a seasoned CEO who is passionate about driving customer success and building teams. I'm confident that he'll be a tremendous addition to the Verista team. About Verista Verista is a leading provider of integrated end-to-end compliance, validation, and digital enablement for the Life Sciences. Headquartered in Fishers, Indiana, Verista is a one-stop partner that connects regulatory expectations with technical execution and digital transformation. Leveraging innovative technologies and over 500 industry experts, Verista empowers organizations to deliver safe, high-quality products efficiently. The Editorial Team at Healthcare Business Today is made up of experienced healthcare writers and editors, led by managing editor Daniel Casciato, who has over 25 years of experience in healthcare journalism. Since 1998, our team has delivered trusted, high-quality health and wellness content across numerous platforms. Disclaimer: The content on this site is for general informational purposes only and is not intended as medical, legal, or financial advice. No content published here should be construed as a substitute for professional advice, diagnosis, or treatment. Always consult with a qualified healthcare or legal professional regarding your specific needs. See our full disclaimer for more details.
Computer Systems Validation services. Verista's comprehensive CSV services offer expert-led validation to ensure regulatory compliance, efficiency, and data integrity across the life sciences industry. Mar 16, 2026 This content was written and submitted by the supplier. It has only been modified to comply with this publication's space and style. Verista, a provider of automation, compliance, and quality solutions for the life sciences industry, highlights their specialized Computer Systems Validation (CSV) services designed to support every phase of the product lifecycle, from research and clinical testing to manufacturing and distribution. CSV is a complex, multi-faceted function that encompasses a broad range of validated computer systems throughout the entire business. From research and clinical testing to manufacturing and distribution, CSV plays a critical role at every stage. The increasing adoption of cloud-based systems alongside traditional on-premise solutions has introduced new layers of complexity, making it even more challenging for organizations to maintain compliance. Verista addresses this challenge by offering managed services that seamlessly integrate quality and compliance functions, including vendor auditing and computer system validation testing. Verista's CSV offering spans the full scope of validated systems across the enterprise. The company enables clients to streamline their validation programs by wrapping quality and compliance functions into a managed services model. This approach ensures that validation, from vendor auditing through testing, is carried out with precision, agility, and audit-readiness. Clients gain measurable value through Verista's expert insight and services, including custom implementations, agile project and audit management, and strategic tool integration. With Verista's support, companies transform their review and approval processes while maintaining compliance and strengthening operational efficiency. The company also offers expert training and ongoing system maintenance, reinforcing best-in-class practices and long-term success. By partnering with Verista, life sciences organizations can confidently implement robust CSV processes that ensure accuracy, reliability, and consistency while safeguarding data integrity and achieving regulatory compliance across all systems and platforms. Companies in this product You're Invited! Don't miss your weekly dose of packaging intelligence and news with Healthcare Packaging's e-newsletter.
Verista acquires Integral Solutions. The unified organization aims to offer clients expanded capacity, deeper technical strength, and integrated project delivery. March 13, 2026 Associate Editor Verista, a provider of automation, compliance, and quality solutions for the life sciences industry, has acquired Integral Solutions, a life sciences business and technology services firm that specializes in engineering and validation services worldwide. The acquisition enhances Verista's capabilities in automation, engineering, project management, and validation, enabling the company to deliver further comprehensive support across the full lifecycle of regulated life sciences operations. By combining Verista's nationwide expertise in computer systems validation, commissioning and qualification, manufacturing and packaging automation, machine vision, and regulatory compliance with Integral's depth in engineering and validation, the unified organization aims to offer clients expanded capacity, deeper technical strength, and integrated project delivery. With the acquisition, Integral Solutions' leadership team, including founder Lou Seich, along with Amy Liddy, Robert Corn, and Wade Cole, and their respective teams, will join Verista. Their experience and long-standing client relationships will help accelerate Verista's growth while ensuring continuity of service and a smooth transition for existing customers.