Job Information
Verista CQV Engineer / Validation Engineer - 5104 in Bloomington, Indiana
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
CQV Engineer Typical Responsibilities:
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
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
Authoring and/or reviewing of SOP’s (both new and existing)
Authoring and/or reviewing Equipment Requirements Specifications
Document calibration and/or maintenance requirements, generate procedures
Troubleshoot manufacturing issues to identify root cause and implement corrective actions
Initiate and/or execute Equipment Impact Assessments on failures.
Collaborate with cross-functional teams to drive continuous improvement efforts
Communicates technical information within the team
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
General understanding of capital equipment implementation and process knowledge
Understanding validation documents, URS, IQ, OQ, PQ
Requirements
Must be willing to work onsite in Bloomington, IN
Bachelor’s Degree or equivalent required
1-3 years of prior demonstrated CQV experience required; regulated industry experience, medical device or pharmaceutical experience highly preferred
Strong technical aptitude and problem-solving skills
Ability to work independently and as part of a team
Attention to detail and ability to maintain accurate records
Communicate effectively with cross-functional teams
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
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
Experience with and tolerance for high levels of challenge and change
Experience in GMP regulated environment
Proven attention to detail and organization in project work
Capable of working on assigned tasks without mentorship
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 Verista.com (https://apply.workable.com/verista/)
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.
$65,000 - $105,591
*Verista is an equal opportunity employer.