MSAT Engineer I
MSAT Engineer I
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$ 66960 - 92070
1 Vacancy
Job Description
Our purpose is to bring hope to life by enabling lifechanging 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 multidepartmental 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
Generate batch records using source data and direction by MSAT staff and in compliance with other departmental needs
Develops and maintains partnership with stakeholders in order to generate supportive documentation for Seattle manufacturing operations
Route MSAT documentation through Quality Management Software and ensure that documentation is reviewed and approved by key subject matter experts in a timely manner
Assist with writing and completing Quality investigations and corrective actions such as CAPAs CRs and Deviations
Assist in providing training on batch record instructions and validation protocol requirements to Manufacturing and Quality Control staff
Drive continuous manufacturing improvements for greater ease of use by collaborating with endusers on their departmental needs
Assist MSAT with any technical questions about documentation or Quality Management Software
SKILLS
Strong collaborative skills with an emphasis on seeking the advisement and gaining the consensus of subject matter experts
Strong writing skills with an emphasis on applying the needs of endusers to manufacturing documentation
Maintain a professional attitude at all times when working with challenging situations or criticisms of work
Strong analytical problem solving skills to support technical transfer of new products
QUALIFICATIONS
Required:
03 years of relevant industry experience
BS/MS in engineering or equivalent experience
Experience with GMP manufacturing or other scientific laboratories procedures
Demonstrated proficiency with Microsoft applications
Demonstrated proficiency in collaborating with various subject matter experts with effective communication skills necessary to interact with internal stakeholders
Preferred:
Experience with SharePoint
Experience with Quality Management Software such as TrackWise Digital
Experience with Upstream and/or Downstream manufacturing operations and equipment
COMPENSATION
$66960 $92070
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 sidebyside with our clients and partners every step of the way. We provide worldclass development and manufacture of mammalian and microbialbased 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 cGMPcompliant facilities in Seattle Washington; Boulder and Longmont Colorado; Copenhagen Denmark; Heidelberg Germany; Milan Italy; and Chiba Japan. We currently employ more than 2500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges including specialization in fasttrack projects and rare diseases. AGC Biologics is the partner of choice. To learn more visitwww.agcbio.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.
Employment Type
Full-Time
