Verista Senior CQV Aseptic Engineer (3884SS) in McPherson, Kansas
Who are we:
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.
Typical Project Accountabilities Include:
Candidates must live within a drivable distance to the client in McPherson, KS or willing to relocate to McPherson, KS
Provide technical CQV (commissioning, qualification, and verification) expertise on modified equipment (aseptic equipment, packaging, and visual inspections), facilities, and utilities ensuring CQV aspects are delivered consistently and efficiently. Includes authoring and executing documents such as URS, System boundary definition, Risk Assessment, Traceability matrices, Design Qualification, Start Up and Debug documentation, commissioning documents, including FAT and SAT, IQ/OQ/PQ, Turnover documentation.
Author and execute technical commissioning and qualification documentation for complex, automated equipment, and processes, in accordance with client’s quality standards, current Good Manufacturing Practices, (21 Code of Federal Regulations Part 210, 211 and 820 level standards which apply to the equipment and product being validated) and national/international standards.
Verify system drawings including ability to review and as-build P&IDs and I&C drawings as well as verifying electrical schematics with electrical engineering support.
Manage and work collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Maintain clear and detailed records of qualification and change control activities for future compliance audits.
Project assignments will vary by customer requirements for specific defined deliverables based on project needs and scope.
Candidates must live within a drivable distance to the client in McPherson, KS or open to relocation.
A minimum of a bachelor’s degree in an Engineering or Scientific degree or equivalent.
6-10 years’ experience in GMP regulated environment.
Aseptic fill and finish experience.
Requires experience writing and executing GMP documentation and Validation protocols, such as IQ/OQ/PQ documents.
Understanding of GMP production facility utilities and their application, such as Water for Injection, Cleanrooms, HVAC, Clean Steam and process gasses
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 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 (https://apply.workable.com/verista/) or follow us on LinkedIn (https://www.linkedin.com/company/veristasolutions/) .
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 - $154,200
*Verista is an equal-opportunity employer.