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Senior CQV Validation Specialist
2 months ago
At Verista, our team of over 600 professionals collaborates with leading organizations in the life sciences sector to address their operational challenges.
Our mission is to foster growth and innovation within the scientific community, assisting researchers, institutions, and companies in tackling some of the most significant healthcare issues globally.
We deliver cutting-edge solutions and services that facilitate informed decision-making, stemming from our substantial investment in our workforce and capabilities.
Our growth is propelled by exceptional individuals who excel in a collaborative environment and share our commitment to helping life sciences clients enhance lives.
Company Culture Guidelines & Values:
We empower and support our colleagues.
We are dedicated to client success at every opportunity.
We possess the courage to act ethically.
We promote an inclusive atmosphere where our colleagues feel valued, engaged, and challenged.
We continuously acquire new skills and learn from our experiences to enhance our collective expertise.
Key Responsibilities of the Senior CQV Validation Specialist:
Execute CQV activities in the field, including HVAC commissioning and qualification, dirty utility commissioning, process gases, water systems, and cleanroom qualifications.
Develop validation plans.
Conduct and document impact and risk assessments with a comprehensive understanding of equipment/system/software operations, assessing direct, indirect, and no-impact systems and functions within intricate processes.
Maintain (and ensure the team maintains) comprehensive, detailed records of qualification and validation, along with change control activities for future compliance audits.
Author, edit, and execute technical commissioning, qualification, and validation documentation for standard equipment/systems/software and processes as directed by the project leader.
Run test scripts and document results.
Adhere to project schedules for all assigned tasks.
Maintain clear, detailed records of qualification and validation activities.
Document impact and risk assessments as part of a collaborative team.
Complete user interface testing, software verification, and comprehensive alarm testing on automated systems.
Develop, review, and execute testing documentation.
Make recommendations for design or process modifications based on test results when executing test scripts.
Possess a general understanding of capital equipment implementation and process knowledge.
Understand validation documents, including URS, IQ, OQ, and PQ.
Requirements:
5-7 years of proven CQV experience in GMP-regulated environments.
Demonstrated expertise in HVAC commissioning and qualification, dirty utility commissioning, process gases, water systems, and cleanroom qualifications.
Exemplary business maturity and interpersonal skills to effectively communicate and collaborate.
Experience and capability to clearly articulate requirements (both written and orally) with rationale to various levels within the client's organization.
Proven attention to detail and organizational skills in project work.
Able to work independently on assigned tasks without mentorship.
GMP and Good Documentation Practice training (may be completed during onboarding).
Intermediate proficiency with WORD (authoring/editing extensive technical documents with styles, tables, TOCs, track changes).
Basic skills in EXCEL and PowerPoint.
Strong interpersonal skills and effective communication abilities.
Must be willing to work onsite in the designated area.
Benefits:
Why Choose Verista?
High growth potential within a fast-paced organization that prioritizes a people-focused culture.
Competitive compensation along with performance-based incentive programs.
Company-sponsored Life, Short-Term, and Long-Term Disability Insurance.
Medical, Dental & Vision insurance options.
Flexible Spending Account (FSA), DCARE, and Commuter Benefits.
Supplemental Life, Hospital, Critical Illness, and Legal Insurance.
Health Savings Account.
401(k) Retirement Plan with Employer Matching benefits.
Paid Time Off (with Rollover Option) and Holidays.
As Needed Sick Time.
Tuition Reimbursement.
Team Social Activities (we believe in having fun).
Employee Recognition Programs.
Employee Referral Incentives.
Paid Parental Leave and Bereavement Support.
For more information about our company, please visit our website.
