5809 - Veeva Change Control Engineer / Quality Lead
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Job Description
Description
Verista's 500 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
The Change Control implementation team consists of a cross-functional Core Team. We are looking for a resource to serve as the Engineer on the Core Team. The Core Team participates in the design and testing of the Veeva Change Control configuration, serves as a subject matter expert for procedure and training development, executes testing during the system validation, and supports users during the system go-live and stabilization period.
Veeva Change Control Engineer Responsibilities:
- Attend team meetings and requirements gathering sessions, execute informal testing of the system (called Process Exercises), give feedback on the configuration of the system, report issues, and retest after configuration changes have been made
- Observe and make connections with other engineers who are change management practitioners
- Represent the interests of the Engineering function in terms of needs in the change control process, understand existing pain points, and bring best practices to the project team to be incorporated in the new global process
- Be the SME responsible for one or more procedures/required tools in the global process
- Work in conjunction with our business integrator to develop and refine these SOPs/required tools
- Serve as the SME for the related training assets. Be the primary point of contact for providing the source materials (SOP, required tools, other resource documents), consulting on questions related to the content, and gathering and evaluating review comments
- Execute designated test scripts and document results according to company procedures
- Participate in the training of power users and will respond to questions from end users during the training period
- Support questions from end users during each go-live and stabilization period that follows
Requirements:
- Technical skills and experience required
- Bachelor's degree in Engineering or related field
- Experience with authoring and executing change controls
- Basic working knowledge of key engineering functions: maintenance and reliability, equipment commissioning and qualification, process automation, and process monitoring
- Knowledge of current Good Manufacturing Processes (GMPs) and previous experience supporting GMP activities
- Experience with global maintenance and reliability systems (GMARS, Lilly's implementation of the IBM Maximo system) and IT-related change systems (such as ServiceNow) is a plus
- Previous experience with Veeva QMS or TrackWise is strongly preferred.
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.
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
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For more information about our company, please visit us at Verista.com
- Location:
- Indianapolis
- Category:
- Manufacturing
