Sr. Microbiology Quality Engineer

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 Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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.

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The Sr Microbiology Quality Engineer is responsible for Leading and managing Complaint Defect Tracking & Resolution (CDT&R) activities for assigned productsincluding complaint trend analysis tracking of significant quality issues and corrective actions triage of incoming complaints and support and coordination of investigations. This role also authors and reviews technically sound investigation summaries and customerfacing reports and interfaces directly with customers through written and verbal communication. The position requires close collaboration with crossfunctional teams to ensure timely compliant and effective resolution of postmarket quality issue

This position reports to the Quality Manager and is part of the Quality Department located in Hauppauge NY and will be an on-site role.

What you will do:

• Lead CDT&R activities for assigned products including complaint triage trend analysis and coordination of investigations to ensure timely and compliant resolution of postmarket quality issues.
• Author and review highquality investigation summaries and customerfacing technical reports and interface directly with customers as needed.
• Provide subject matter expertise on containment actions root cause analysis investigation execution and CAPA planning for internal nonconformances.
• Manage field actions and facilitate formal risk assessments ensuring appropriate escalation documentation and regulatory compliance.
• Generate and present quality metrics related to nonconformances CAPAs complaints and field actions contribute to continuous improvement initiatives and apply microbiological laboratory competence.

Who you are:

• Bachelors degree with a preference for candidates with a microbiology background and/or advanced education or professional training through ASQ or a relevant professional society or a masters degree program
• Minimum of five years of relevant industry experience in a regulated environment such as GMP medical devices or pharmaceuticals is required along with at least three years of hands-on experience coordinating post market surveillance and quality assurance activities including complaint triage investigations and CAPA management; four to six years of such experience is preferred
• Demonstrated microbiology laboratory competence including microscopic differentiation of microorganisms (bacteria yeast mold) Gram staining and environmental monitoring in controlled manufacturing environments.
• Proficiency with Microsoft Excel (formulas pivot tables) PowerPoint Word and Teams and experience analyzing data using statistical tools.
• Experience with cGMP and/or ISO 13485 quality systems including documentation practices audits postmarket surveillance change control and validation

Travel Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel up to 10%
• Must have a valid drivers license with an acceptable driving record
• Ability to lift move or carry equipment up to 50lb any other physical requirements

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

• Advanced statistical analysis tools like Minitab or quality engineering certifications
• Working knowledge of USP 61 & 62

Cytiva a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

The salary range for this role is 00. 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.

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

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 Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

Join our winning team today. Together well accelerate the real-life impact of tomorrows 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.

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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- or .