Senior CQV Engineer - 4589
Verista, United States
Job Description
Verista’s600 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 amp; 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:
- Engineer will be responsible for the qualification of an ESCO isolator system
- Responsible for the creation and execution of validation protocols
- Responsible for reviewing existing documentation and determining necessary additional testing per Annex 1 requirements
- Secondary support of feasibility studies
- Designing validation plans
- Conducting and documenting impact and risk assessments with a full understanding of equipment/system/ software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes
- Maintaining (and ensuring the team maintains) clear, detailed records of qualification and alidation, and change control activities for future compliance audits
- Independently understanding client’s quality standards, cGMP’s, and regulatory standards to support team in compliance of validation effort
- Independent verification of testing against specifications
- Managing and working collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis.
- Supporting clients change management program including authoring proposed changes, executing impact assessments/ regression analysis, and supporting client documentation of change results and release
Requirements
- Must be willing to work onsite Watertown, MA
- Demonstrated experience in execution of Smoke Studies
- Experience of classifying Isolators and defining regulatory requirements and required validation activities
- Designing and executing engineering studies for critical process parameter definition and verification prior to validation
- Bachelor’s Degree or equivalent required
- Proficiency using PC and Microsoft Office tools
- Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
- Ability to work as part of a team
- Strong problem-solving and critical thinking skills
- Excellent organizational and time management skills
- Strong attention to detail
- GMP and Good Documentation Practice
- Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
- Basic skills with EXCEL and PowerPoint
- Strong interpersonal skills and clear communication capabilities
- Experience with and tolerance for high levels of challenge and change.
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 amp; 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 atVerista.com
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