Engineer II, Process Validation
Danaher · Fargo, ND
- Level
- Engineer
- Team
- Quality
- Travel
- 5%
- Degree
- Required
- Experience asked
- 2+ years
- Industry
- Pharma & life sciences
- Posted
- 30+ days ago
The role in 30 seconds
An engineer-level quality role at Danaher (pharma & life sciences) in Fargo, ND. Design, execute, analyze, and summarize deliverables across the three stages of process validation supporting process characterization and qualification spanning critical starting materials, drug substance, and drug product, product classifications aligned.
- They ask for
- 2+ years · degree required
- Tools it names
- Kaizen, Root cause, FMEA, DOE, FDA / GMP, Validation (IQ/OQ/PQ)
- Day to day
- about 5% travel
Read from the posting. The full description is below.
From the plant jobs report · week of October 19, 2026
Quality Engineer roles in the US: typical posted base $96k–$135k.
Median of the low and high ends of 464 live postings that list pay, out of 1137 quality engineer openings in the US, read from manufacturers' own careers sites.
North Dakota plant jobs report →Pay by team and state →What moves pay →
How this role compares
Against 1136 other live quality postings in the US.
- Base pay
- Not listed in this posting
- Experience asked
- Less than usual (2+ vs 5+)
Typical $95k–$135k, from 446 postings that list pay.
Similar roles usually ask 5+ years.
Skills these teams ask for most
- ✓ Root cause 68%
- ✓ FMEA 40%
- Supplier quality 39%
- ✓ Validation (IQ/OQ/PQ) 37%
- Six Sigma 36%
- Lean 34%
✓ = this posting asks for it too. % = share of similar postings that mention it.
Stands out: this posting asks for Kaizen, which few similar roles mention. If you have it, lead with it.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
How to get in at this plant
Five moves over a week or two. The first one takes ten minutes.
- 1
Pick 2–3 people on the Quality team at Danaher
Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.
- 2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
- 3
Turn a reply into a short call
Questions worth asking about this team:
- What does a normal week look like on your team?
- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
- How much of the job is customer complaints versus prevention?
- The posting says about 5% travel. Between which sites?
- How did you land the job? What stood out in your interviews?
- 4
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
Full description from DanaherAs posted on their careers site.ShowHide
In this role, you will have the opportunity to
- ◆Design, execute, analyze, and summarize deliverables across the three stages of process validation supporting process characterization and qualification spanning critical starting materials, drug substance, and drug product, product classifications aligned with FDA guidance, EU GMP Annex 15, and lifecycle approach.
- ◆Drive risk-based approaches using tools such as pFMEA, risk ranking, and criticality assessments and apply statistical tools to evaluate process performance, including but not limited to process capability, trend analysis and control charts and DOE interpretation.
- ◆Serve as a technical SME for process validation with external clients, across internal teams such as MSAT, manufacturing, QC, QA and RA, and during client audits and regulatory inspections, kaizens and workshop events.
The essential
requirements
and cGMP regulations for pharmaceutical manufacturing operations and validation procedures and practices.
- ✓Proficiency in technical writing with deviation investigations, root cause analysis, and risk assessments.
Travel, Motor Vehicle Record & Physical/Environment
Requirements
- ✓Ability to travel 5% of the time to support audits and client visits.
- ✓Ability to lift, move or carry equipment up to 10 lbs.
It would be a plus if you also possess previous experience in
- ✓Client facing roles such as prior experience in a CDMO environment
- ✓Sterile fill-finish process and equipment
qualifications
Aldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info .
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com .
The U.S. EEO posters are available here .
For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here .
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or applyassistance@danaher.com .
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Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Aldevron, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
At Aldevron, we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation for genomic medicine pioneers . As a member of our team, you’ll help bring life-changing innovations to life—impacting millions around the world. We bring together deep scientific expertise, an unwavering commitment to quality, and a collaborative spirit to drive progress. Whether you're launching your career or bringing years of experience, we value the unique perspective you bring. Join us and become part of a mission-driven team advancing science and unlocking human potential—one discovery at a time.
Learn about the Danaher Business System which makes everything possible.
The Engineer II, Process Validation is responsible for leading & supporting internal and external validation projects that enable commercialization of vital new life saving medicines.
This position reports to the Process Validation Manager and is part of the Technical Operations Department located in Fargo, ND and will be an on-site role .
of the job include
- •Bachelor’s or master’s degree in engineering with 2+ years of experience.
- •Prior experience in leading deliverables across all three stages of process validation in biologics/small and large molecules manufacturing train with a thorough understanding of the manufacturing process.
- •Knowledge of global regulatory