6467 - Senior CSV Engineer / Senior Validation Engineer

Veristainc; Harvard (MA); On-site; USD 80,000 - 132,000; Full time

Benefits offered by this job

401(k) Retirement Plan (Employer Match

Tuition Reimbursement

Paid Time Off—Holidays

Job summary

Verista is seeking a Senior CSV/CSA Engineer to lead validation activities for standalone bioprocess equipment in a Devens, MA facility. You will own the CSV lifecycle, coordinate with CQV, QA, IT, and vendors, and ensure compliance with 21 CFR Part 11 and EU Annex 11.

The role requires a Bachelor’s degree in Engineering/Life Sciences/CS and 7+ years of validation experience, with hands-on work validating standalone GMP manufacturing equipment and a strong grasp of data-integrity concepts.

Qualifications

• Seven+ years of CSV/CSA or computerized-equipment validation experience in a regulated life-sciences environment.
• Hands-on experience validating standalone GMP manufacturing equipment.
• Strong understanding of 21 CFR Part 11, EU Annex 11, GAMP 5 and data-integrity principles.
• Experience validating access security, audit trails, electronic signatures, and electronic records.
• Ability to review functional specifications, configuration specifications and system architecture.

Responsibilities

• Develop and execute the CSV/CSA strategy for standalone GMP equipment systems.
• Review equipment and software architecture, intended use and GxP impact.
• Author or review validation plans, system assessments, risk assessments and supplier assessments.
• Review URS, functional specifications, configuration specifications and design documentation.
• Develop and execute risk-based test protocols.
• Evaluate vendor FAT, SAT, IQ and OQ documentation for leveraged testing.
• Test user access, roles, permissions and account administration.
• Test audit trails, electronic records and electronic signatures.
• Verify recipe, method and configuration controls.
• Test alarms, events, reports, data capture and record retention.
• Verify backup, restoration, archival, time synchronization and disaster-recovery controls.
• Assess compliance with 21 CFR Part 11, EU Annex 11 and applicable data-integrity requirements.
• Maintain requirements traceability and validation-documentation packages.
• Manage discrepancies, deviations, corrective actions and validation-summary reporting.
• Support change control, SOP development, training and system release.

Skills

CSV/CSA validation

GxP

21 CFR Part 11

SOPs and validation documentation

Independent work with vendors

Education

Bachelor’s degree in Engineering/Life Sciences/Computer Science

Tools

UNICORN

KlariFi

Lucullus

Kneat

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 Senior CSV/CSA Engineer to lead validation activities for standalone, computerized bioprocess equipment being installed in a single-use manufacturing facility. The equipment will utilize UNICORN, KlariFi and Lucullus software and will not be integrated with the site DeltaV system.The engineer will own or lead the computer-system validation lifecycle while coordinating with Process Engineering, CQV, Automation, Quality, IT, equipment vendors and system owners.

Senior Validation Engineer Responsibilities:

• Develop and execute the CSV/CSA strategy for standalone GMP equipment systems
• Review equipment and software architecture, intended use and GxP impact
• Author or review validation plans, system assessments, risk assessments and supplier assessments
• Review URS, functional specifications, configuration specifications and design documentation
• Develop and execute risk-based test protocols
• Evaluate vendor FAT, SAT, IQ and OQ documentation for leveraged testing
• Test user access, roles, permissions and account administration
• Test audit trails, electronic records and electronic signatures
• Verify recipe, method and configuration controls
• Test alarms, events, reports, data capture and record retention
• Verify backup, restoration, archival, time synchronization and disaster-recovery controls
• Assess compliance with 21 CFR Part 11, EU Annex 11 and applicable data-integrity requirements
• Maintain requirements traceability and validation-documentation packages
• Manage discrepancies, deviations, corrective actions and validation-summary reporting
• Support change control, SOP development, training and system release

Job Requirements:

• Bachelor’s degree in Engineering, Life Sciences, Computer Science or a related discipline
• Approximately seven or more years of CSV, CSA or computerized-equipment validation experience in a regulated life-sciences environment
• Hands-on experience validating standalone GMP manufacturing equipment
• Strong understanding of 21 CFR Part 11, EU Annex 11, GAMP 5 and data-integrity principles
• Experience testing access security, audit trails, electronic signatures, recipes, reports and computerized records
• Ability to review functional specifications, configuration specifications and system architecture
• Strong protocol authoring, execution and deviation-management skills
• Ability to work independently with equipment vendors, engineers and Quality representatives
• Direct experience with UNICORN, KlariFi or Lucullus
• Experience with chromatography, tangential-flow filtration or bioreactor systems
• Experience validating PLC/HMI-or SCADA-controlled equipment
• Familiarity with Kneat or another electronic validation lifecycle system
• Experience supporting new-equipment installation and capital-project execution

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

$80,465 — $131,685 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

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For more information about our company, please visit us at Verista.com