Back to jobs

6468 - Senior CQV Engineer / Senior Validation Engineer

Devens, Massachusetts

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.

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

$80,465 - $122,603 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

Verista collects and processes personal data in accordance with applicable data protection laws.  If you are a California Job Applicant, see the privacy notice for further details. 

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

Create a Job Alert

Interested in building your career at Verista, Inc.? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Education

Select...
Select...
Select...

Current residential street address (e.g. 1600 Pennsylvania Ave NW)

Please enter the city where you currently reside.

Select...

State in which you currently reside.

What are your specific areas of expertise?

Select...

Enter number of years of experience within the Life Sciences Industry, regardless of role.

Enter your number of years of role specific experience.

List any certifications your hold?

Select...
Select...

Traveling to support client needs are an expectation of Verista Resources.  Are you open to at least 50% travel?

Select...

Can you meet the travel and on-site requirements defined for this role?

Select...

Sponsorship question

Select...
Select...

U.S. Standard Demographic Questions

We invite applicants to share their demographic background. If you choose to complete this survey, your responses may be used to identify areas of improvement in our hiring process.
Select...
Select...
Select...
Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Verista, Inc.’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...