Hiring · posted Oct 25
Genentech · Biotechnology
Principal Validation Engineer, CVRM
- Holly Springs, NC
- On-site
- Full-time
- Senior & Principal
The role
Develops, implements and maintains validation status of the application equipment and manufacturing processes. Estimates qualifications needs, material needs and verifies pre requisite completions. Works independently within guidelines and policies, and receives minimal guidance. Acts as a resource for colleagues with less experience and provides functional guidance.
The Principal Validation Engineer will be accountable for performing activities such as Equipment Commissioning and Qualification, Cycle Development (CD), Performance Qualification (PQ) and Re-Qualification (RPQ) / Cleaning Validation (CV) and Process Validation (PV) in support of technology transfer and new technology introduction to the Hollysprings, North Carolina site.
Welcome to Holly Springs, North Carolina— home to Genentech's largest-ever investment with an ambitious goal to be a fully connected Plant of the Future. This is where next-generation technology, capability, digital connectivity and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing. This will include Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products.
The facility's core is defined by innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant will not only meet today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines but is a strategic commitment to be scalable with this portfolio, which serves one of the largest patient populations in the world. This is a fast-paced, highly entrepreneurial environment with a high-level of accountability from the site team to launch operations in 2028.
Are you a problem-solver and change agent who thrives in a High-Performing Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to not only launch a state-of-the-art facility from the ground-up but to shape the culture of our organization for the next generation.
Join us in Holly Springs, where you won't just build a plant—you will build the future of medicine.
What you need
- BS/MS in chemical, biochemical engineering, or related field/experience, with a minimum of 8+ years experience in drug product Process Research & Development, Engineering, Manufacturing, or Technical Services is required.
- Experience in the pharma/biotech industry is required
- Knowledge of cGMPs or equivalent regulations
- Working knowledge of facilities, utilities, formulation, filling, and packaging, equipment qualification in a regulated environment is required. Hands on qualification experience with the majority of sterile filling equipment and support systems.
- Demonstrated project management skills
- Ability to work with internal teams, partners, suppliers and customers
- Operational excellence and industrial engineering skills are a plus
- Professional level written and oral communication skills required
Relocation benefits are available for this position.
The expected salary range for this position based on the primary location for this position of Holly Springs, North Carolina is $95,000 - $176,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
Link to Benefits
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
What you'll do
- Develop and manage the detailed project plans, validation plans and timelines for the execution of validation activities.
- Author, execute and summarize various qualifications for sterilization systems and equipment, cleaning system, filling equipment and supporting equipment (Autoclaves, Parts washer etc.).
- Prepare change control documentation, including protocols, summary reports, etc., for all activities.
- Support project manager ensuring new systems are implemented within predetermined timelines and financial forecasts.
- Present and provide rationale for completed work during periodic audits and Health Authority inspections.
- Procure and manage contractor support for outsourced validation and risk management assignments.
- Support the change management system for new processes, equipment, utilities and facilities.
- Prepare, review and approve relevant sections of regulatory submissions.
- Serve as a risk management representative on cross-functional and multi-site teams to support integrating risk management into various Product Quality Systems (PQS) such as, Discrepancy Management, Change Control and CAPA.
- Lead and facilitate Risk Assessment sessions.
- Provide input into investigations and change control with potential impact to the site risk profile.
- Foster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements.
- Mentor more junior validation engineers and train individuals on practices and procedures.
- Closely collaborates with site and network organizations seamlessly
- Constantly in search of the most creative and innovative solutions to maintaining the highest levels of productivity
- Able to provide the leadership necessary to maintain a high performance culture
Pay and benefits
$95,000 – $176,000 a year
Employer providedRelocation benefits
Discretionary annual bonus
Where you'll work
Holly Springs, NCOn-siteOpen in Maps (opens in a new tab)
More jobs in Holly Springs, NCEqual opportunity, accessibility and legal noticesGenentech's statements, word for word
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
This role's midpoint is 12% above the US median for Validation & CQV roles at this level.
This roleEmployer provided
Senior & Principal roles in North Carolina6 roles publishing pay
Senior & Principal roles in the US55 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $95,000 | — | $176,000 |
| North Carolina (middle half) | $99,500 | $117,500 | $149,000 |
| All US (middle half) | $110,750 | $121,500 | $133,500 |
This role: Genentech's own published range. Comparisons: the base pay employers published on open Validation & CQV roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 127 open Validation & CQV roles on Regulatory Jobs, with the titles they carry most. Not Genentech's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 34 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- Validation and qualification6
- Quality systems and risk6
- GMP and compliance3
- Documentation and SOPs2
- Investigations and CAPA2
- Regulatory submissions2
- Clinical trial conduct1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Genentech on Regulatory Jobs
- 26
- Open roles
- 25
- Distinct roles
- 6
- Locations
By discipline
- Quality15 58%
- Regulatory7 27%
- Clinical4 15%
By level
- Senior & Principal20 77%
- Director3 12%
- VP & Executive1 4%
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Principal Validation Engineer, CVRM at Genentech
Open until filled. $95K–$176K a year, employer provided.