Pharma Validation Lead Engineer (Senior CQV)

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

Benefits offered by this job

Competitive pay

401(k) matching

Health insurance

Paid time off

Tuition reimbursement

Job summary

Verista in Boston is seeking a Senior CQV Engineer to design validation plans and lead qualification activities for pharmaceutical manufacturing. You will assess risk, document results, and ensure compliance with GMP and Good Documentation Practice while collaborating with cross-functional teams.

The role requires 4–6 years of CQV experience, onsite work in the Boston area, strong communication and mentoring abilities, and proficiency with WORD, Excel, and PowerPoint.

Qualifications

• Bachelor’s degree or equivalent is required.
• 4–6 years of demonstrated role-relevant experience.
• Demonstrated experience in leading CQV activities for pharmaceutical manufacturing.
• Ability to work onsite in the Boston area and travel up to 50%.

Responsibilities

• Designing validation plans.
• Documenting impact and risk assessments with understanding of equipment, systems, and software.
• Maintaining records of qualification, validation, and change control activities.
• Designing and executing studies for critical parameter definition and verification prior to validation.
• Authoring, editing, and executing CQV documentation for equipment, systems, and processes.
• Running test scripts and documenting results.
• Adherence to project schedule for all assigned activities.
• Documenting impact and risk assessments as part of a team.

Skills

Communication

GMP experience

Documentation

Problem solving

Time management

Attention to detail

Team player

Mentoring

Client communication

Education

Bachelor’s Degree or equivalent

Tools

Microsoft Word

Excel

PowerPoint

Job description

Verista in Boston is seeking a Senior CQV Engineer to design validation plans and lead qualification activities for pharmaceutical manufacturing. You will assess risk, document results, and ensure compliance with GMP and Good Documentation Practice while collaborating with cross-functional teams.

The role requires 4–6 years of CQV experience, onsite work in the Boston area, strong communication and mentoring abilities, and proficiency with WORD, Excel, and PowerPoint.