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Verista · 2 days ago

5831- Senior CQV Engineer / Senior Validation Engineer 2

Holly Springs, NC

Full-time

Onsite

Mid, Senior Level

$80K/yr - $123K/yr

4+ years exp

Verista is a company that partners with leading brands in the life science industry to address critical healthcare challenges. They are seeking a Senior CQV Engineer to support commissioning, qualification, and validation processes, ensuring compliance and quality in pharmaceutical manufacturing environments.

ComplianceHealth CareLife ScienceManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Upstream/downstream process and CQV support (ex. autoclaves, parts washers, incubators, Isolators, HVAC)

Managing and working collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis

Supporting clients change management program – including authoring proposed changes, executing impact assessments/ regression analysis, and supporting client documentation of change results and release

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

Qualification

Commissioning & ValidationGMP knowledgeAutomated systems testingTechnical documentationRisk-based approachCommunication skillsProblem-solving skillsBasic Excel skillsBasic PowerPoint skillsTeamworkAttention to detailOrganizational skillsTime managementInterpersonal skillsAdaptability

Required

Must be able to meet onsite work requirements in Holly Springs, NC

Bachelor of Science in Technical Field (engineering, life science, or equivalent) from accredited institution

Minimum 4 years technical experience

Demonstrated experience in Commissioning & Validation activities covering URS (GMP equipment)

Demonstrated experience authoring and executing FAT, SAT, IOQ, CSV Protocols

Experience in a pharmaceutical / FDA-regulated manufacturing environment. A solid working knowledge of cGMP and facility/equipment validation requirements

Communication Skills: Excellent oral and written communication skills, including presentations

Ability to write clearly, concisely, and persuasively in a professional environment

Demonstrated ability to interact effectively with all levels of the organization

Demonstrated understanding of risk-based approach to commissioning & qualification

Experience with testing of automated manufacturing equipment / systems (e.g., PLC-controlled)

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

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

Company

Verista

Verista offers transformative compliance, automation, packaging solutions for the life sciences, pharmaceutical and manufacturing.

Founded in 1983

Fishers, Indiana, USA

501-1000 employees

https://www.verista.com/

H1B Sponsorship

Verista has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (7)

2024 (4)

2023 (13)

2022 (6)

2021 (1)