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Job Information
Verista Laboratory Business Analyst (SME) / Lead Validation Engineer - 4893 in Indianapolis, Indiana
Verista’s 600 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
Senior CQV Engineer Responsibilities:
• Lead a Team through the qualification effort of making a lab and its equipment compliant to regulations and company procedures
• Manage the validation and documentation related to complex computer systems, multiple pieces of equipment/large upgrades/extensive product updates
• Perform functions of validation engineer – draft Validation Plans, Requirements, Test Cases, Summary Reports
• Manage the systems and processes for change control and coordinate evaluation of proposed changes on laboratory equipment
• Change management process owner for validation involving new or modified equipment, processes, procedures, and products. In this role, validation engineers design and perform validation around lab equipment and computer systems
• Determine and delegate tasks amongst a team to complete assignment
• Conduct impact analysis for validation and change management
• Coordinate teams to complete validation testing activities
• Manage complete document management and approval through client’s process
• Conducts regulatory impact analysis/assessment and, where warranted, makes recommendations.
• Act as the Subject Matter Expert on various pieces of lab equipment
Requirements
• A minimum of a Bachelor’s degree in an Engineering or Scientific degree and five to ten years industry experience
• Demonstrated experience leading complex Laboratory qualification projects
Preferred:
• 7+ years’ experience in GMP regulated environment (with Internship or co-op work experience considered as part of that experience)
• Direct experience authoring/editing/executing validation documents for laboratory equipment (Cat. A, B &C)
• Expert knowledge of FDA regulations, ISPE guidelines and ISO standards including:
Good Documentation Practice (GDP) in pharmaceutical environment
21 CFR Part 11
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
For more information about our company, please visit us at Verista.com (https://apply.workable.com/verista/)
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.
$87,780-145,725
*Verista is an equal opportunity employer.