Quality Engineer - Validation & Change Control

Danaher • Muskegon, MI

7d • Onsite

About The Position

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, 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. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career. Learn about the Danaher Business System which makes everything possible. The Quality Engineer will be the subject matter expert for the validation strategy and maintain ownership of the Muskegon site Validation Master Plan. This position reports to the Quality Assurance Manager and is part of the Quality Assurance Department located in Muskegon, MI and will be an on-site role.

Requirements

• Bachelor's degree from an accredited University or College, preferably in a Science or Engineering discipline.
• Multiple years working experience in Quality Assurance/Quality Engineering.
• Experience in equipment qualifications, process validations, cleaning validations and computer software validations.
• Previous experience in root cause, corrective action, preventative action and process improvement.
• Understanding of ISO 9001, Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP) requirements.
• Ability to travel up to 10% a year.
• Must have a valid driver’s license with an acceptable driving record.
• Ability to lift, move or carry equipment up to 10lb frequently, and up to 25lbs infrequently.

Nice To Haves

• Life Science, Pharmaceutical, Medical Device or Biopharma manufacturing environments.
• Analytical and problem-solving skills.
• Strong communication skills (written and oral) with associates at all levels of the organization.

Responsibilities

• Review and approve user requirement documentation (URS), Failure Mode Effect Analysis (FMEA) and equipment Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), process validation (PV), cleaning validation (CV) protocols and/or Plans and Reports.
• Assist and approve deviation investigations, corrective and preventative actions (CAPAs), process improvements related to equipment qualification and validation activities.
• Be the subject matter expert for Change Control on launched products, managing the local Change Management Board.
• Improve and develop QMS work instructions and cross train as a backup for other QA members.
• Participate in quality walks and internal audits to ensure compliance with industry standards.

Benefits

• Cytiva, 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 .
• This job is also eligible for bonus/incentive pay.
• We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees