Principal CSV Engineer Analyst - 3705MC

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 & 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 & Validation) activities.

This role requires onsite work in Grand Rapids, MI

Typical Responsibilities Include:

• 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.
• Complex lab system validation strategy planning and execution.

Requirements

• 5+ 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)
• Ability to take independent leadership role on project(s).
• Proven ability to identify areas of business expansion and initiate technical discussion on Verista solutions for business expansion.
• Intermediate knowledge of FDA regulations, ISPE guidelines and ISO standards including:
  • Good Documentation Practice (GDP) in pharmaceutical environment
  • 21 CFR Part 11

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 & 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.

*Verista is an equal-opportunity employer.

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.

Salary Range: $85,500 - $120,000

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