Senior Engineer, Process Validation (Remote)

Danaher Corporation; Sunnyvale (CA); Remote; USD 100,000 - 130,000; Full time

Benefits offered by this job

Remote work eligibility

Competitive benefits

401(k) plan

Bonus eligibility

Job summary

Aldevron, a Danaher operating company, seeks a Senior Engineer, Process Validation to lead validation projects enabling the commercialization of new life-saving medicines. The role is fully remote and reports to the Process Validation Manager within Technical Operations in Fargo, ND, with travel as needed.

You will design, execute and summarize validation deliverables across sterile fill-finish, starting materials, drug substance, and drug product; apply risk-based methods and DOE; mentor junior

Qualifications

• Bachelor or master degree in engineering and 5+ years of experience.
• Prior experience in leading process development, engineering, and deliverables across all three stages of process validation in biologics/small and large molecules manufacturing train using statistical analysis, risk assessment, and process improvement tools required.
• 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.

Responsibilities

• Design, execute, and summarize deliverables across the three stages of process validation supporting process characterization and qualification spanning starting materials, drug substance, and drug product, product classifications aligned with FDA guidance, EU GMP Annex 15, and lifecycle approach.
• Lead the planning, execution, and lifecycle management of sterile fill-finish process validation strategies and qualification programs for aseptic manufacturing processes including sterile filtration, aseptic process simulation, sterile filling, visual inspection, container closure integrity testing, filter validation, labelling, packaging and shipping.
• 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.
• Mentor junior validation associates in Process Validation, cGMP regulations, and principles of Quality by Design

Skills

Process validation

Statistical analysis

Regulatory compliance

Risk management

Mentoring

Education

Bachelor's or Master in Engineering

Tools

pFMEA

Control charts

DOE

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 (https://danaher.com/our-businesses) 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 (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

The Senior Engineer, 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 fully remote.

In this role, you will have the opportunity to:

• Design, execute, 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.

• Lead the planning, execution, and lifecycle management of sterile fill-finish process validation strategies and qualification programs for aseptic manufacturing processes including sterile filtration, aseptic process simulation, sterile filling, visual inspection, container closure integrity testing, filter validation, labelling, packaging and shipping.

• 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.

• Mentor junior validation associates in Process Validation, cGMP regulations, and principles of Quality by Design

The essential requirements of the job include:

• Bachelor or master degree in engineering and 5+ years of experience

• Prior experience in leading process development, engineering, and deliverables across all three stages of process validation in biologics/small and large molecules manufacturing train using statistical analysis, risk assessment, and process improvement tools required.

• 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 15% to site to support validation project executions, routine inspections, audits, and client visits.

It would be a plus if you also possess previous experience in:

• Packaging and shipping validation of final product container closure configurations.

• Client facing roles such as prior experience in a CDMO environment

• 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 (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) .

• We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

At Aldevron we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Aldevron can provide.

The annual salary range for this role is $100,000 to $130,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

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For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

The U.S. EEO posters are available here (http://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .

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 [e-mail].