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Service Engineer (GxP)

Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio!

AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics.

The AmplifyBio ecosystem is comprised of three distinct business units: ADOC (South San Francisco, CA)– Amplify’s Discovery, Optimization, and Characterization laboratories: ASET (West Jefferson, OH) – Amplify’s Safety, Efficacy, and Toxicology Site; and the most recently opened AMEC (New Albany, OH) – Amplify’s Manufacturing Enablement Center. 

About ADOC South San Francisco, CA.  AmplifyBio’s discovery optimization and characterization unit (ADOC) establishes critical product characterization benchmarks, optimizes efficacy, and identifies new targets and strategies for clients preparing to scale up the production of therapeutic candidates. The site also houses GMP manufacturing suites, and quality labs available to clients. Based on broad experience in cell and gene therapy manufacturing, this group seeks to address the widening gap between R&D and manufacturing CMC.

AmplifyBio is seeking to hire an Engineer II to join our growing team!!!

What You’ll Do Here:

  • Be the first line of contact for equipment support and communicate with lab users and the development teams to perform troubleshooting and solve equipment related issues.
  • Work with vendors to schedule service calls and negotiate contracts.
  • Working on cross functional teams to develop and improve automated processes.  
  • Performing regular maintenance, calibration, and troubleshooting procedures on liquid handlers, and lab equipment.
  • Writing and performing verification and validation test protocols and reports including IQ/OQ/PQ. 
  • Performing Operator training and maintaining training records.
  • Improving tools, reporting, and operational documents for tracking spare parts, service calls, and repair decision-making. 

We Would Love to Hear from You If:

  • Bachelors of Science degree in Engineering, Biology, Chemistry, or related field of study.
  • Minimum of 5 years industry experience supporting production laboratory operations. 
  • 2 + years hands-on experience focused on service and support of liquid handlers (Hamilton, Tecan, Beckman, Agilent etc.) and integrated automation solutions. 
  • 3 + years hands-on experience focused on service and support of complex lab equipment including sequencers, FACS, LCMS, HPLCs, and flow cytometers. 
  • Familiarity with the principles of continuous process improvement (Lean, Six Sigma, or QbD). 
  • Experience working in a regulated environment (GxP/CLIA/CAP).  
  • Highly goal-driven and have demonstrated the ability to effectively prioritize and focus on time-sensitive objectives. 
  • Have great communication skills working with cross-functional teams and presenting data to a diverse audience.

Desired But Not Required:

  • Experience with IBM Maximo Asset Tracking system or similar.
  • Service support experience with integrated systems and multiple liquid handling platforms: Hamilton, Tecan, Beckman, Agilent etc.  
  • 3 + years of experience investigating, developing, and implementing complex laboratory or manufacturing processes.
  • Experience with instrument integrations and scheduling software (GBG/Momentum).
  • Experience programming in python, Perl, C#, or similar.
  • Experience using incident tracking software Jira or similar. 
  • Experience with the principles of continuous process improvement (Lean, Six Sigma, or QbD).  
  • Experience supporting and deploying hardware into production environments with robust validation/verification requirements (cGMP, CLIA, CAP, ISO 13485) and stringent IQ/OQ/PQ.
  • Hands-on experience with bacterial and/or mammalian cell culture, protein and nucleic acid purification, microfluidics, and genome engineering platforms (e.g. CRISPR, TALENs).  

At AmplifyBio we’re committed to growing and empowering an inclusive community within our company and industry. This is why we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization.

AmplifyBio is an equal opportunity employer, and we value diversity at our company. We don’t discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law.   

Why You Will Love Working Here:
We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work. From a wellness program, to financial planning and legal assistance, we make sure to take care of our own.

  • Health, Dental, and Vision insurance that starts on your first day at AmplifyBio
  • Competitive Compensation Package
  • We take work-life balance seriously and we back it up with a FLEIXIBLE PTO program!
  • Generous paid parental leave
  • Wellness and Self-Care Programs
  • 401(k) match
  • Tuition Reimbursement
  • EAP/work-life support system
  • A fun work environment where everyone’s voice matters
  • We are just getting started! More benefits on the way!
  • An Opportunity to Change the World!!!

When you join our team, you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians, and specialists across a variety of disciplines. The future for AmplifyBio is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees.

Apply Today!

Scaling science for life.