Senior QA CSV Engineer Analyst - 3528SS
Verista, United States
Job Description
Verista’s 700 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. Whether it’s compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.
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 amp; 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
Verista is currently seeking Validation Engineers with experience in facilities, equipment and process validation within a pharmaceutical or biotechnology manufacturing environment to support CQV (Commissioning, Qualification amp; Validation) activities.
Typical Responsibilities Include:
- Representative of Quality in regards to CSV
- Reviewing and releasing quality related CSV project deliverables
- Ensuring CSV deliverables meet global procedures, regulatory requirements and policies
- Being a Subject Matter Expert (SME) and providing guidance and recommendations to internal or and external project stakeholder
- Experience in GAMP5, experience defending ICH and CFR guidelines, facilitating risk assessments, review and approval of discrepancies and deviations
Requirements
- Bachelor or higher in computer science, engineering, life science or related field
- Significant working experience in pharmaceutical industries and cGMP-controlled environment. At least 5 years in GMP industry.
- Needs to be comfortable in the digital space.
- Experience in GAMP5, experience defending ICH and CFR guidelines, facilitating risk assessments, review and approval of discrepancies and deviations.
- Excellent working knowledge in EU and US GMP regulations relevant for audit/inspections, qualification/validation, compliance systems
- Working experience in Quality Assurance
- Excellence in Good Documentation Practices (GPD)
- Significant working experience in Computer System Validation (CSV) SDLC
- Knowledge in CSV, Data Integrity and related Guidelines (21 CFR Part 11, EU GMP Annex 11, GAMP5 and the underlying principles of each)
- Excellent communication and decision-making skills
- Fluency in written and spoken English
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Benefits
Why Verista?
- High growth potential and fast paced organization with a people-focused culture
- Competitive pay plus performance-based incentive programs
- Company paid medical premiums.
- Company paid Life, Short-Term, and Long-Term Disability insurances
- Dental amp; Vision insurances
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- Leadership development training, career planning, and tuition reimbursement
- Team Social Activities (We have fun!)
- Employee Recognition
- Employee Referral Program
- Paid Maternity, Parental Leave and Bereavement
Verista is a leading business, technology and compliance company that enables clients 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. This experience brings together decades of knowledge, the most advanced engagement platforms, as well as transformative technologies. This allows clients to benefit from the ease, efficiency, and trust that results from working with one partner who excels across specialties.
For more information about our company, please visit us at Verista.com or follow us on LinkedIn.
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.
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