Lead CQV Validation Engineer / Lead Validation Engineer

Verista

Rocky Mount (NC)

On-site

USD 87,780 - 154,389

Full time

14 days+

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Benefits offered by this job

Company-paid Life Insurance

Medical, Dental & Vision Insurance

401(k) Retirement Plan

Paid Time Off

Tuition Reimbursement

Team Social Activities

Employee Recognition

Paid Parental Leave

Job summary

An established industry player is seeking a Lead CQV Validation Engineer to join their dynamic team in Rocky Mount, NC. In this pivotal role, you will lead validation projects, ensuring compliance with regulatory standards while mentoring junior staff. The company fosters a culture of growth and innovation, empowering employees to make a significant impact in the life sciences sector. With a focus on teamwork, you will collaborate closely with clients and internal teams to drive successful project outcomes. This is an exciting opportunity to be at the forefront of healthcare solutions, contributing to meaningful advancements in the industry.

Qualifications

10+ years of relevant experience in validation and project management.
Ability to lead validation programs and mentor team members.

Responsibilities

Design and execute validation projects for pharmaceutical systems.
Consult clients on regulatory validation processes and compliance.

Skills

Project Management

Validation Expertise

Regulatory Compliance

Problem-Solving

Interpersonal Skills

Communication Skills

Education

Bachelor's Degree

Tools

Microsoft Project

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

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

The CQV Validation Engineer family of roles execute commissioning, qualification and validation projects involving new or modified systems/equipment, processes, procedures, products, facilities, and utilities. In this role, validation engineers support the validation and change lifecycles for client’s systems in pharmaceutical and medical device manufacturing, and packaging operations to meet timeline, budget, quality, regulatory compliance, and client expectations.

Lead CQV Validation Engineer Responsibilities

A recognized leader in the industry and senior individual capable of designing and executing validation projects of any scope, scale, or level of complexity
Actively consult clients on regulatory validation processes and standard industry acceptable practices
Support validation audits and large-scale remediation efforts
Act as subject matter expert in all areas of system compliance and validation
Managing the responsibilities on multiple simultaneous projects and/or clients
Driving the activities as client facing leader and responsible party
Act as the defined point of escalation and issue management on client projects
Fluent in working with equipment OEMs and installation vendors
Designing validation plans
Conducting and documenting impact and risk assessments with a full understanding of equipment/system/ software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes
Maintaining (and ensuring the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance audits
Independently understanding client’s quality standards, cGMP’s, and regulatory standards to support team in compliance of validation effort
Designing and executing engineering studies for critical process parameter definition and verification prior to validation
Independent verification of testing against specifications
Managing and working collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities
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 qualification and validation records
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

Requirements

10+ years of role relevant experience
Direct experience managing all phases of capital equipment procurement, installation, and validation
Demonstrated capability to deliver on the Validation Subject Matter Expert Responsibilities
Demonstrated industry expert on validation principles
Capable of delivering industry lectures and trainings on applicable experiences
Capable of identifying, proposing, and selling Verista services to clients
Demonstrated industry expertise in area of focus
Ability to take independent leadership role on project(s)
Proven ability to identify areas of business expansion and initiate technical discussion on Verista solutions for business expansion
Demonstrated project leadership capabilities
Ability to architect validation programs and execute against complex project tasks
Advanced Microsoft Project capabilities
Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate
Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client’s organization
Ability to mentor and guide less experienced team members
Ability to communicate effectively with clients
Proven ability to identify areas of business expansion and report to management team for follow-up
Experience in pharmaceutical cGxP setting with the ability to generate CQV deliverables independently
Proven attention to detail and organization in project work
Ability to work independently and as part of a team, with the ability to transition between the two
Bachelor’s Degree or equivalent required
Capacity to make independent sound decisions and independently manage priorities
Advanced Microsoft WORD, EXCEL, and PowerPoint capabilities.
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)
Strong interpersonal skills and clear communication capabilities
Experience with and tolerance for high levels of challenge and change

This is a 100% onsite role in Rocky Mount, NC.

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: $87,780—$154,389 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

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

Seniority level