Process Engineering Scientist

Process Engineering Scientist, Technical Operations

Position Summary:

The Process Engineering Scientist I is responsible for all duties relating to the transfer of manufacturing processes from the development group into manufacturing and for assisting manufacturing with preparing for and execution of successful manufacturing campaigns. The Process Engineering Scientist I must interact closely with Aldevron Madison and Aldevron Fargo scientific teams to ensure all project requirements are met. Additionally, the Process Engineering Scientist I is expected to interact with clients in scientific reviews and updates.

Essential Duties and Responsibilities:

* Support technology transfer of upstream (bacterial culture) and downstream (purification) protein manufacturing process into manufacturing
* Provide technical and operational support to manufacturing team
* Interact with production personnel in generation of batch records and SOP's, engineering runs, and training on equipment and production processes
* Assist with generation of related documents including master batch records, SOP's, and process test plans and summary reports
* Travel to site of process development to train on new processes and assist in transfer of processes to the manufacturing site
* Work with the development groups to ensure that transferred processes are converted into scalable manufacturing processes that are GMP compliant and meet Aldevron business critical needs
* Collaborate with cross-functional teams and business units to ensure efficient process transfer
* Support CAPA's/deviations through technical evaluations and laboratory investigations. May act as a principal investigator to ensure CAPA's are investigated and closed properly
* Support continuous improvement projects addressing process efficiency, product costs, and performance
* Participate in technical calls and routine project updates with Aldevron clients
* Provide timeline and milestone updates on tech transfers
* Create summary slides and present technical information, including process development/optimization data, investigation findings and remediations, and manufacturing updates

* Generate, review, and approve Raw Material Authorization documentation for new incoming materials
* Generate and maintain bill of materials in the inventory management system for all protein processes
* Ensure all long-lead items required for manufacturing are procured prior to the time needed
* Lead engineering runs for new manufacturing processes and ensure successful training and transfer of processs into GMP production
* Work collaboratively with Validation department to design and execute process validation plans
* Demonstrate high ethical standards, good judgement, and trustworthiness
* Perform other duties, as assigned

Qualifications:

Required Experience:

* 3 or more years of experience in process development or GMP biologics manufacturing, preferably involving protein production
* Experience involving tech transfer or process development
* Experience with AKTA chromatography systems

Desired Experience:

* Experience with automated TFF systems
* Experience with single-use systems
* Experience with Microsoft Dynamics 365
* Experience working within a Quality Management System, performing root cause investigations, developing and tracking CAPAs

Education:

* Degree in biology, biotechnology, molecular biology, biochemistry, chemistry, or a closely related field

Skills and Knowledge:

* Excellent written and verbal communication skills
* Proficient with Microsoft Office
* Must be able to work in a fast paced environment and multi-task
* Knowledge of GMP's and regulatory requirements for biologics manufacturing

When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

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. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at [ Email address blocked ] - Click here to apply to Process Engineering Scientist to request accommodation.

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