Top 93 Engineer ii, process validation Jobs in Fargo, Nd

Engineer II, Process Validation
Aldevron —Fargo, ND
- Full-time
- Engineering
- Mid-level
- Travel
- Paid time off
Maintenance Engineer II
Essentia Health —Fargo, ND
- $21.08 - $31.62 an hour
- Full-time
- Mid-level
- 3 years
- Clinic
- Disability insurance
- Health insurance
Quick Apply
11d
Senior Manager, Outside Plant (OSP) Construction
Ziply Fiber —Fargo, ND
- $96,800 - $159,500 a year
- Microsoft Word
- Background check
- Microsoft Excel
- Health insurance
- Dental insurance
Quick Apply
Card Network Ops Specialist III
Choice Bank —West Fargo, ND
- Full-time
- Mid-level
- 3 years
- Analysis skills
Technical Project Manager II (Client-facing RNA/ DNA Mfg., Method Development/ Validation)
Aldevron —Fargo, ND
- Full-time
- Clean driving record
- Microsoft Outlook
- Mid-level
- Health insurance
- Dental insurance
Enterprise Quality Engineer II
Marvin —Fargo, ND
- Full-time
- Mid-level
- SharePoint
- Leadership
- Profit sharing
- Paid parental leave
Enterprise Quality Engineer I
Marvin —Fargo, ND
- Full-time
- Product management
- SharePoint
- Communication skills
- Profit sharing
- Paid parental leave
Lead Data Center Support Services Technician
Oracle —Harwood, ND
- Computer science
- Computer Science
- Bachelor of Science
Senior Support Engineer
Oracle —Harwood, ND
- Weekends as needed
- Mentoring
- Training & development
- Senior level
8d
Quality Data Analyst
Sanford Health —Fargo, ND
- $24.00 - $38.50 an hour
- 8 hour shift
- Background check
- 6 years
- Pass drug screening
- Health insurance
- Dental insurance
Quick Apply
Manager, Data Center Support Services
Oracle —Harwood, ND
- Full-time
- Office
- Mentoring
- Senior level
Field Engineer II - Contractor (1099)
Acuative Corporation —Fargo, ND
- Contract
- Background check
- Pass drug screening
- Mid-level
Quick Apply
5d
Manager, Technical Project Management (CDMO, Client-facing RNA/ DNA Mfg., Method Development/ Validation)
Aldevron —Fargo, ND
- Full-time
- Bachelor's degree
- Travel
- In-person
- Health insurance
- Dental insurance
Software Engineer II
Choice Bank —Fargo, ND
- Full-time
- Computer science
- Computer Science
- Mid-level
Manufacturing Engineer II
Marvin —Fargo, ND
- $82,000 - $100,000 a year
- Full-time
- Engineering
- Mid-level
- Team management
- Profit sharing
- Paid parental leave
Fraud Risk Analyst
U.S. Bank National Association —Fargo, ND
- $105,400 - $124,000 a year
- Full-time
- 6 years
- Computer Science
- Mid-level
- Paid holidays
- Disability insurance
SAP Cloud Integration Engineer II
Border States Industries, Inc. —Fargo, ND
- Remote
- Azure
- Customer service
- 5 years
- Health savings account
- Paid holidays
Agricultural Data & Systems Engineer
North Dakota State University —Fargo, ND
- $69,069 - $92,092 a year
- Full-time
- Azure
- Computer Science
- Master's degree
- Wellness program
- Health savings account
2d
Principal Engineer, Fill and Finish, Technical Operations
Aldevron —Fargo, ND
- Full-time
- Engineering
- Ability to lift 50 pounds
- Continuous improvement
- Paid time off
5d
Post Doctoral Research Fellow (Liu/UDA)
North Dakota State University —Fargo, ND
- From $50,000 a year
- Full-time
- Analysis skills
- University
- Doctor of Philosophy
- Wellness program
- Health savings account
3d

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engineer ii, process validation jobs near fargo, nd

Engineer II, Process Validation

Aldevron -
Fargo, ND

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Job Details

Full-time

Benefits

Paid time off

Qualifications

Biotechnology
Content creation for technical audiences
Defect resolution root cause analysis
Technical documentation
Pharmaceutical regulatory compliance
Defect analysis
Drug regulation
Technical writing experience within manufacturing
Production deviation management
GMP
Production validation processes
Pharmaceutical company experience
Root cause analysis
Pharmaceutical manufacturing facility experience

Full Job Description

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.

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 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 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.

Apply Now

Refine Your Search

engineer ii, process validation jobs in fargo, nd

Engineer II, Process Validation

Maintenance Engineer II

Senior Manager, Outside Plant (OSP) Construction

Card Network Ops Specialist III

Technical Project Manager II (Client-facing RNA/ DNA Mfg., Method Development/ Validation)

Enterprise Quality Engineer II

Enterprise Quality Engineer I

Lead Data Center Support Services Technician

Senior Support Engineer

Quality Data Analyst

Manager, Data Center Support Services

Field Engineer II - Contractor (1099)

Manager, Technical Project Management (CDMO, Client-facing RNA/ DNA Mfg., Method Development/ Validation)

Software Engineer II

Manufacturing Engineer II

Fraud Risk Analyst

SAP Cloud Integration Engineer II

Agricultural Data & Systems Engineer

Principal Engineer, Fill and Finish, Technical Operations

Post Doctoral Research Fellow (Liu/UDA)

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