CQV / Validation Engineer - 4865
Posted on Sep 22, 2024 by Verista
Indianapolis, IN
Research
Immediate Start
Annual Salary
Full-Time
Verista’s 600 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
Responsibilities:
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.
Reading technical schematics to identify, locate, and test photo sensors, verify part numbers, and complete I/O testing on automated manufacturing equipment.
General understanding of capital equipment implementation and process knowledge.
Understanding validation documents, URS, IQ, OQ, PQ.
Verifying system drawings including ability to review and as-built P&IDs (piping and instrumentation drawings) and I&C (instrumentation and controls) drawings as well as verifying electrical schematics with support of an electrical engineer.
Change Control Support (TrackWise): author, monitor, and ensure closure:
Initiate technical team meeting
Develop/write required change controls and implementation steps with information obtained from the Impact Assessment(s).
Submit change controls to appropriate personnel for review – make modifications/updates based on feedback and review comments.
Submit change controls to appropriate personnel for approval.
Notify appropriate personnel of change control approval and subsequent steps.
Monitor change control status regularly after approval and ensure full completion of tasks.
Initiate change control amendments and extension requests, as required.
Utilize VeevaVault and Kneat for documentation
Work daily with SMEs, Quality, etc.. on change controls and projects
Learn and train as potential deviation investigator
Requirements
Bachelor’s Degree or equivalent required.
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 training (may be completed at onboarding).
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.
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
For more information about our company, please visit us at
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.
<$70,941.00 to $80,000.00>
*Verista is an equal opportunity employer.
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
Responsibilities:
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.
Reading technical schematics to identify, locate, and test photo sensors, verify part numbers, and complete I/O testing on automated manufacturing equipment.
General understanding of capital equipment implementation and process knowledge.
Understanding validation documents, URS, IQ, OQ, PQ.
Verifying system drawings including ability to review and as-built P&IDs (piping and instrumentation drawings) and I&C (instrumentation and controls) drawings as well as verifying electrical schematics with support of an electrical engineer.
Change Control Support (TrackWise): author, monitor, and ensure closure:
Initiate technical team meeting
Develop/write required change controls and implementation steps with information obtained from the Impact Assessment(s).
Submit change controls to appropriate personnel for review – make modifications/updates based on feedback and review comments.
Submit change controls to appropriate personnel for approval.
Notify appropriate personnel of change control approval and subsequent steps.
Monitor change control status regularly after approval and ensure full completion of tasks.
Initiate change control amendments and extension requests, as required.
Utilize VeevaVault and Kneat for documentation
Work daily with SMEs, Quality, etc.. on change controls and projects
Learn and train as potential deviation investigator
Requirements
Bachelor’s Degree or equivalent required.
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 training (may be completed at onboarding).
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.
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
For more information about our company, please visit us at
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.
<$70,941.00 to $80,000.00>
*Verista is an equal opportunity employer.
Reference: 202144566
https://jobs.careeraddict.com/post/95508883
CQV / Validation Engineer - 4865
Posted on Sep 22, 2024 by Verista
Indianapolis, IN
Research
Immediate Start
Annual Salary
Full-Time
Verista’s 600 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
Responsibilities:
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.
Reading technical schematics to identify, locate, and test photo sensors, verify part numbers, and complete I/O testing on automated manufacturing equipment.
General understanding of capital equipment implementation and process knowledge.
Understanding validation documents, URS, IQ, OQ, PQ.
Verifying system drawings including ability to review and as-built P&IDs (piping and instrumentation drawings) and I&C (instrumentation and controls) drawings as well as verifying electrical schematics with support of an electrical engineer.
Change Control Support (TrackWise): author, monitor, and ensure closure:
Initiate technical team meeting
Develop/write required change controls and implementation steps with information obtained from the Impact Assessment(s).
Submit change controls to appropriate personnel for review – make modifications/updates based on feedback and review comments.
Submit change controls to appropriate personnel for approval.
Notify appropriate personnel of change control approval and subsequent steps.
Monitor change control status regularly after approval and ensure full completion of tasks.
Initiate change control amendments and extension requests, as required.
Utilize VeevaVault and Kneat for documentation
Work daily with SMEs, Quality, etc.. on change controls and projects
Learn and train as potential deviation investigator
Requirements
Bachelor’s Degree or equivalent required.
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 training (may be completed at onboarding).
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.
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
For more information about our company, please visit us at
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.
<$70,941.00 to $80,000.00>
*Verista is an equal opportunity employer.
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
Responsibilities:
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.
Reading technical schematics to identify, locate, and test photo sensors, verify part numbers, and complete I/O testing on automated manufacturing equipment.
General understanding of capital equipment implementation and process knowledge.
Understanding validation documents, URS, IQ, OQ, PQ.
Verifying system drawings including ability to review and as-built P&IDs (piping and instrumentation drawings) and I&C (instrumentation and controls) drawings as well as verifying electrical schematics with support of an electrical engineer.
Change Control Support (TrackWise): author, monitor, and ensure closure:
Initiate technical team meeting
Develop/write required change controls and implementation steps with information obtained from the Impact Assessment(s).
Submit change controls to appropriate personnel for review – make modifications/updates based on feedback and review comments.
Submit change controls to appropriate personnel for approval.
Notify appropriate personnel of change control approval and subsequent steps.
Monitor change control status regularly after approval and ensure full completion of tasks.
Initiate change control amendments and extension requests, as required.
Utilize VeevaVault and Kneat for documentation
Work daily with SMEs, Quality, etc.. on change controls and projects
Learn and train as potential deviation investigator
Requirements
Bachelor’s Degree or equivalent required.
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 training (may be completed at onboarding).
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.
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
For more information about our company, please visit us at
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.
<$70,941.00 to $80,000.00>
*Verista is an equal opportunity employer.
Reference: 202144566
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