6372 - CSV-Data Integrity Lead / Lead Validation Engineer
Devens, Massachusetts, United States · On-site
$88k–$140k/yr
Senior+
Description 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 sc…
Skills: Computer Systems Validation, Data Integrity, Equipment Qualification, Technical Writing, Stakeholder Coordination
6362 - Analytical Instrument SME / Senior Validation Engineer
Devens, Massachusetts, United States · On-site
$80k–$129k/yr
Senior+
Description 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 sc…
6363 - CQV Project Controls Lead / Senior Program Manager
Devens, Massachusetts, United States · On-site
$102k–$159k/yr
Senior+
Description 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 sc…
Skills: Project Controls, Schedule Coordination, RAID Tracking, Governance, Change Control
6407 - Senior CSA Analyst – Plasma Systems & Site Enablement / Senior CSV Engineer
King of Prussia, Pennsylvania, United States · On-site
$70k–$118k/yr
Senior
Description 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 sc…
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$88k–$140k/yr
Full-time
bachelor degree
Life Insurance, Short-Term Disability Insurance, Long-Term Disability Insurance, Medical Insurance, Dental Insurance, Vision Insurance
Posted 34d ago
~40 hrs/week
Responsibilities
Lead the CSV and Data Integrity strategy for computerized equipment qualification deliverables. Author and revise critical validation documentation including URS, IOQ, and PQ while partnering with SMEs and quality teams.
Requirements
Requires a Bachelor's degree in Engineering or Life Sciences with over 8 years of CSV or validation experience in GMP environments. Must have expertise in biologics manufacturing and proficiency with ValGenesis.
Full job description
Description
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 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
Job Overview: We are seeking a Computer Systems Validation / Data Integrity Lead to support qualification deliverables for equipment with computerized system and data integrity components. The primary focus will be CSV and related DI deliverables, including DI URS, commissioning protocol support, IOQ, individual and grouped DI OQ, UAT, DIRA, PQ, and QSR documentation.
Lead Validation Engineer Responsibilities:
Lead CSV/DI strategy for computerized equipment qualification deliverables
Author/revise DI URS, IOQ, DI OQ, UAT, DIRA, PQ, and QSR documentation
Support computerized system impact assessments and data integrity risk considerations
Partner with equipment SMEs, CQV lead, quality, automation/IT, and vendor teams
Support execution, discrepancy resolution, and package closeout
Ensure documentation aligns with GMP, data integrity, and site validation expectations
Support Phase 1 and Phase 2 CSV/DI deliverables as required
Job Requirements:
Bachelor's degree in Engineering, Life Sciences, or a related technical discipline
8+ years CSV, CSA, CQV, or validation experience in GMP environments
Experience with computerized equipment qualification and data integrity deliverables
Experience authoring/executing IQ/OQ/PQ, UAT, DI assessments, DIRA, and QSRs
Strong technical writing and stakeholder coordination skills
Experience with GMP process/lab systems
Experience in biologics manufacturing
Experience with ValGenesis
This role requires the ability to be on-site, full-time in Devens, MA.
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.
*Verista is an equal opportunity employer.
National (US) Range
$87,780—$140,220 USD
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
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.
For more information about our company, please visit us at Verista.com
Related keywords
CSVData IntegrityGMPCQVCSAURSIOQOQPQUATDIRAQSRBiologics ManufacturingValGenesisLife SciencesComputerized Systems Validation
A full-service approach to managing GxP across the product lifecycle.
Industry
Pharmaceutical Manufacturing
Company size
501-1,000 employees
Headquarters
Fishers, Indiana
LinkedIn followers
37,181
Verista is a leading business and technology consultancy firm that provides systems, compliance, validation and quality solutions to life science companies - enabling them to improve health and improve lives. We help clients solve their most critical and complex challenges across the GxP lifecycle, from preclinical and clinical to commercialization, manufacturing and distribution – bringing together decades of knowledge, the most advanced engagement platforms and transformative technologies. This allows clients to benefit from the ease, efficiency and trust that results from working with one partner who excels across specialties. Verista’s clients trust the company’s 650+ experts to deliver consistent, safe, and high-quality results across the product development lifecycle. Verista is based in Fishers, Indiana, Wayne, Pennsylvania, Westford, Massachusetts, and San Mateo, California. For more information, visit www.verista.com
Offices: 9100 Fall View Dr, Fishers, Indiana 46037, US · 950 W Valley Rd, Suite 2400, Wayne, Pennsylvania 19087, US · 1 Technology Park Dr., Suite 1, Westford, Massachusetts 01886, US · 400 Concar Dr,, San Mateo, CA 94402, US
computer system validationCQVQMSautomation engineeringR&Dmachine vision 21 CFR Part 11lab systems & informaticsEnterprise ITpackaging
A full-service approach to managing GxP across the product lifecycle.
Industry
Pharmaceutical Manufacturing
Company size
501-1,000 employees
Headquarters
Fishers, Indiana
LinkedIn followers
37,181
Verista is a leading business and technology consultancy firm that provides systems, compliance, validation and quality solutions to life science companies - enabling them to improve health and improve lives. We help clients solve their most critical and complex challenges across the GxP lifecycle, from preclinical and clinical to commercialization, manufacturing and distribution – bringing together decades of knowledge, the most advanced engagement platforms and transformative technologies. This allows clients to benefit from the ease, efficiency and trust that results from working with one partner who excels across specialties. Verista’s clients trust the company’s 650+ experts to deliver consistent, safe, and high-quality results across the product development lifecycle. Verista is based in Fishers, Indiana, Wayne, Pennsylvania, Westford, Massachusetts, and San Mateo, California. For more information, visit www.verista.com
Offices: 9100 Fall View Dr, Fishers, Indiana 46037, US · 950 W Valley Rd, Suite 2400, Wayne, Pennsylvania 19087, US · 1 Technology Park Dr., Suite 1, Westford, Massachusetts 01886, US · 400 Concar Dr,, San Mateo, CA 94402, US
computer system validationCQVQMSautomation engineeringR&Dmachine vision 21 CFR Part 11lab systems & informaticsEnterprise ITpackaging