6458 - Senior CQV Engineer / Senior Validation Engineer

Verista, Inc.; Boston (MA); On-site; USD 70,491 - 109,900; Full time

Benefits offered by this job

Life insurance

Disability insurance

Health insurance

401(k) retirement plan

Paid time off

Holidays

Job summary

Verista is seeking a Senior CQV Engineer in the Boston area to design validation plans, assess risks, and maintain qualification records for complex equipment, systems, and software. You will author CQV documentation and run test scripts as part of a committed project team.

Ideal candidates have 4–6 years of CQV experience in pharmaceutical manufacturing, strong communication skills, mentoring ability, and GMP knowledge. Onsite work and potential travel are expected.

Qualifications

• Must be able to work onsite in the Boston metropolitan area.
• 4–6 years of demonstrated role relevant experience.
• Experience leading CQV activities specific to pharmaceutical manufacturing requirements.
• Ability to mentor and guide less experienced team members.
• Strong communication with clients and teams.
• GMP and Good Documentation Practice knowledge.

Responsibilities

• Designing validation plans and documenting impact and risk assessments.
• Maintaining clear, detailed records of qualification, validation, and change control activities.
• Authoring, editing, and executing CQV documentation for equipment, systems, software, and processes.
• Running test scripts and documenting results.
• Adherence to project schedules for all assigned activities.
• Developing/testing documentation and recommending design or process changes based on results.

Skills

Mentoring

Communication

GMP knowledge

Problem-solving

Detail-oriented

Teamwork

Education

Bachelor’s Degree or equivalent

Tools

Microsoft Word

Microsoft Excel

PowerPoint

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.

Senior CQV Engineer Responsibilities

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 validation, and change control activities for future compliance audits Designing and executing engineering studies for critical process parameter definition and verification prior to validation Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader Running test scripts and documenting results Adherence with project schedule for all assigned activities Maintaining clear, detailed records qualification and validation Documenting impact and risk assessments as part of a team Completing user interface testing, software verification, and complete alarm testing on automated systems Developing, reviewing, and executing testing documentation Making recommendations for design or process modification based on test results when executing test scripts General understanding of capital equipment implementation and process knowledge Understanding validation documents, URS, IQ, OQ, PQ

Requirements

Requirements: Must be able/willing to work onsite in the Boston metropolitan area Must be willing to meet potential future travel requirements (10-50%) Bachelor’s Degree or equivalent required Ability to mentor and guide less experienced team members Ability to communicate effectively with clients Proven ability to identify areas of business expansion and report to management team for follow-up Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client’s organization 4 - 6 years of demonstrated role relevant experience Demonstrated experience in leading CQV activities specific to pharmaceutical manufacturing requirements 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 Experience in GMP regulated environment Proven attention to detail and organization in project work Capable of working on assigned tasks without mentorship

Salary

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 $70,491 — $109,900 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

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