Verista, Inc.
6468 - Senior CQV Engineer / Senior Validation Engineer
Devens, Massachusetts · Senior · Full-time
Sponsorship not specified$80k-$123kDetected 23 days ago
Mechanical DesignGMP
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odds of building a lasting career here
47Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level II)66
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~30% per draw at Level II). Good if you win; have a cap-exempt backup on your list.
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About the role
- The engineer will work closely with Process Engineering, Automation, CSV, Quality, equipment vendors and Operations.
Responsibilities
- Support design reviews and equipment-system assessments.
- Support equipment FAT and SAT activities.
- Perform equipment walkdowns and verify installation against approved drawings and specifications.
- Support commissioning, startup and turnover activities.
- Develop and execute commissioning, IQ and OQ documentation.
- Support loop checks and I/O verification.
- Support pump, valve, flow, pressure, temperature, weight and mixing-function testing.
- Support PID-loop verification and process stabilization.
- Document discrepancies and support investigation and resolution.
- Support engineering runs, water runs, buffer runs and initial process execution.
Requirements
- Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biochemical Engineering or a related discipline.
- Approximately five or more years of equipment commissioning, qualification, process engineering or validation experience in biotechnology or pharmaceutical manufacturing.
- Experience with bioprocess equipment such as TFF skids, bioreactors, chromatography systems or single-use processing equipment.
- Experience executing FAT, SAT, commissioning, IQ or OQ activities.
- Ability to read P&IDs, functional specifications, control narratives and I/O documentation.
- Experience testing alarms, interlocks, permissives and automated operating sequences.
- Ability to work directly with vendors, Operations, Engineering and Quality.
- Experience with single-use bioreactors.
- Experience with PID-controlled process systems.
- Experience supporting equipment startup within a new or renovated GMP facility.
Nice to have
- Experience with KrosFlo, ÄKTA chromatography and UNICORN preferred.
Compensation
- For US geography, the salary range for this position is shown below.
Benefits
- Company-paid Life, Short-Term, and Long-Term Disability Insurance.
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- Tuition Reimbursement
- Paid Parental Leave and Bereavement
Company info
- 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.
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