
5544- Analytical Validation Specialist III / Validation Engineer 2
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 Analytical Validation Specialist III role will assist validation activities including, but not limited to, software updates, new system introduction, and decommissioning of analytical systems. The individual will work closely with Senior Analytical Validation Specialists and other functional groups to contribute to quality, and right first time performance. This role requires closer support from other Subject Matter Experts and Management.
Responsibilities:
- Develop Technical Knowledge and documentation on analytical equipments
- Provide Subject Matter Expert support for troubleshooting of analytical equipments
- Assist and support the planning and execution of validation plans involving analytical equipment changes
- Perform advanced troubleshooting and advanced helpdesk tickets (template creations, focus control etc.)
- Execution of Installation Qualifications/Operational Qualifications and Performance Qualifications
- Own change requests and complete change request tasks to support project completion
- Assist in Generating User Requirements Specification Documentation
- Complete Electronic Records/Electronic Signatures, Data Integrity Risk Assessments and Audit Trail Risk Assessments
- Review analytical equipment, manuals, and help devise validation plans
- Identify Quality Issues, involve stakeholders, help drive to completion/resolution
- Assist in completion of Correct Actions/Preventative Actions
- Review/Approve Commissioning Qualification Validation Documents
- System Acceptance Ownership and Completion
- Vendor escorting as needed
- Demonstrates ownership and remediation of Data Integrity
- Performs other duties as assigned
Requirements:
- Bachelor of Science degree highly preferred in a science related discipline or relevant experience in the field
- Good working knowledge on Validation deliverables and Data Integrity principles
- Working knowledge and experience with Quality Systems including deviations, change controls, CAPAs, OTNs, deviations; both the system (TrackWise) and the practical applications in operations
- Knowledgeable in process, equipment, cleaning, and computer system validations to the extent of being able to effectively review and approve protocols and reports and support implementation of new equipment
- Demonstrate sound decision making
- Ability to work inter-departmentally and with customers
- Demonstrates role model behaviors for GMP and Safety behaviors
- Strong written and verbal communication skills
- Ability to work in MS Project, Word, Excel, PowerPoint
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.
National (US) Range
$65,000 - $99,500 USD
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
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.
For more information about our company, please visit us at Verista.com
Create a Job Alert
Interested in building your career at Verista, Inc.? Get future opportunities sent straight to your email.
Apply for this job
*
indicates a required field