Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.
JOB SUMMARY
The Engineer I provides support for biotechnology manufacturing by generating supportive documentation and operational assistance of Right First Time manufacturing. Working under the guidance of multi-departmental staff, individuals in this role take part in generating key MSAT documentation, resolving technical issues, and providing documentation training to Manufacturing and Quality Control staff. The Engineer I has a high degree of personal integrity and can work independently. The Engineer I continuously seeks subject matter experts’ knowledge and integrates that knowledge into MSAT documentation.
ESSENTIAL JOB DUTIES/RESPONSIBILITIES
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Generate batch records using source data and direction by MSAT staff, and in compliance with other departmental needs
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Develops and maintains partnership with stakeholders in order to generate supportive documentation for Seattle manufacturing operations
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Route MSAT documentation through Quality Management Software, and ensure that required documentation is reviewed and approved by key subject matter experts in a timely manner
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Assist with writing and completing Quality investigations and corrective actions, such as CAPAs, CRs, and Deviations
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Assist in providing training on batch record instructions and validation protocol requirements to Manufacturing and Quality Control staff
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Drive continuous manufacturing improvements for greater ease of use by collaborating with end-users on their departmental needs
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Assist MSAT with any technical questions about documentation or Quality Management Software
SKILLS
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Strong collaborative skills with an emphasis on seeking the advisement and gaining the consensus of subject matter experts
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Strong writing skills with an emphasis on applying the needs of end-users to manufacturing documentation
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Maintain a professional attitude at all times when working with challenging situations or criticisms of work
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Strong analytical problem solving skills to support technical transfer of new products
QUALIFICATIONS
Required:
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0-3 years of relevant industry experience
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BS/MS in engineering or equivalent experience
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Experience with GMP manufacturing or other scientific laboratories procedures
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Demonstrated proficiency with Microsoft applications
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Demonstrated proficiency in collaborating with various subject matter experts with effective communication skills necessary to interact with internal stakeholders
Preferred:
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Experience with SharePoint
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Experience with Quality Management Software, such as TrackWise Digital
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Experience with Upstream and/or Downstream manufacturing operations and equipment
COMPENSATION
$66,960 - $92,070
Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
Top Skills
What We Do
AGC Biologics offers deep industry expertise and uniquely customized services for the scale-up and cGMP manufacture of protein-based therapeutics (using mammalian and microbial systems), mRNA, pDNA, viral vector and cell therapy products, from pre-clinical to commercial production, including our proprietary CHEF1TM Expression System for efficient protein production with CHO cells.
Our company DNA drives us to provide innovative solutions to partner with our customers in helping them reach their goals and accelerate their projects at our cGMP-compliant facilities in the US, Europe and Japan, as well as to facilitate approval and manage spending during the product lifecycle.
We forge exceptionally strong partnerships with our customers and we never lose sight of our commitment to deliver reliable and compliant drug substance.
Visit www.agcbio.com to learn more.
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