6468 - Senior CQV Engineer / Senior Validation Engineer

Socket.dev; Harvard (MA); On-site; USD 80,000 - 123,000; Full time

Benefits offered by this job

401(k) matching

Paid time off

Health/Dental/Vision

Health Savings Account

Job summary

Verista is seeking a Commissioning and Qualification Engineer to support installation, startup, commissioning and qualification of single-use bioprocess equipment. You will collaborate with Process Engineering, Automation, QA and Operations to translate process needs into testing protocols.

The role requires experience with FAT/SAT, IQ/OQ, and documentation development, plus strong field execution and collaboration with vendors. On-site in Devens, MA is required.

Qualifications

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biochemical Engineering or a related discipline.

Responsibilities

• Support design reviews and equipment-system assessments.
• Review URSs, P&IDs, process-flow diagrams, equipment specifications and vendor documentation.
• Review control narratives, functional specifications and I/O lists.
• 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.
• Verify instrumentation, calibration status, utilities and equipment components.
• Support loop checks and I/O verification.
• Challenge alarms, interlocks, permissives and equipment safety functions.
• Test equipment operating sequences, recipes, phases and process transitions.
• Support pump, valve, flow, pressure, temperature, weight and mixing-function testing.
• Support PID-loop verification and process stabilization.
• Coordinate punch-list resolution and system turnover.
• Document discrepancies and support investigation and resolution.
• Support engineering runs, water runs, buffer runs and initial process execution.
• Provide process and equipment SME support during CSV testing.
• Support SOPs, operating instructions, maintenance procedures and training.

Skills

Field execution

Troubleshooting

Technical writing

P&ID reading

I/O documentation

Vendor collaboration

Process engineering

Education

Bachelor’s degree in Chemical/Mechanical/Biochemical Engineering or related

Tools

KrosFlo

ÄKTA chromatography

UNICORN

KlariFi

Lucullus

DeltaV

Single-use bioreactors

Job 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

Job Overview:

We are seeking a Commissioning and Qualification Engineer to support the installation, startup, commissioning and qualification of new single-use bioprocess equipment. The engineer will work closely with Process Engineering, Automation, CSV, Quality, equipment vendors and Operations. This position requires strong equipment and process knowledge, with the ability to translate process requirements into meaningful commissioning and qualification testing.

Senior Validation Engineer Responsibilities:

• Support design reviews and equipment-system assessments.
• Review URSs, P&IDs, process-flow diagrams, equipment specifications and vendor documentation.
• Review control narratives, functional specifications and I/O lists.
• 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.
• Verify instrumentation, calibration status, utilities and equipment components.
• Support loop checks and I/O verification.
• Challenge alarms, interlocks, permissives and equipment safety functions.
• Test equipment operating sequences, recipes, phases and process transitions.
• Support pump, valve, flow, pressure, temperature, weight and mixing-function testing.
• Support PID-loop verification and process stabilization.
• Coordinate punch-list resolution and system turnover.
• Document discrepancies and support investigation and resolution.
• Support engineering runs, water runs, buffer runs and initial process execution.
• Provide process and equipment SME support during CSV testing.
• Support SOPs, operating instructions, maintenance procedures and training.

Job 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.
• Strong field-execution, troubleshooting and technical-writing skills.
• Ability to work directly with vendors, Operations, Engineering and Quality.
• Experience with KrosFlo, ÄKTA chromatography and UNICORN preferred.
• Experience with single-use bioreactors.
• Exposure to KlariFi, Lucullus or DeltaV.
• Experience with PID-controlled process systems.
• Experience supporting equipment startup within a new or renovated GMP facility.

This role requires the ability to be on-site, full-time in Devens, MA.

National (US) Range

$80,465—$122,603 USD

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.

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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For more information about our company, please visit us at Verista.com