Senior CQV Engineer - 4589

 

Main characteristics

Location

Watertown, Massachusetts

Company

Verista

Industry

Engineering

Job summary

Veristas 600 experts team up with the worlds 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 worlds 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

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 clients quality standards, cGMPs, 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

Bachelors 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 & 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 at

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.

$70,491 - $111,689

*Verista is an equal opportunity employer.