Open Roles

Bioprocess Associate/Quality Control Associate

Help patients by supporting the manufacturing of the cures and therapies used to treat the diseases afflicting the patients. Seeking candidates for a variety of roles in biomanufacturing, including bioproduction associate, quality control associate, upstream bioprocess engineer/specialist, and downstream bioprocess engineer/specialist.

Role and responsibilities

Bioprocess Associate

  • Perform bioproduction operations of clinical and commercial protein therapeutics
  • Execution of manufacturing according to production records and protocols
  • Operate production equipment according to Standard Operating Procedures (SOPs) such as bioreactors, Wave rocker, chromatography skids, media mix tank and filtration units
  • Abide by Good Manufacturing Practices (cGMP) and standard operating procedures
  • Assemble, cleans, and sterilize reagents and equipment to support bioproduction operations
  • Work on a dynamic team to achieve production goals

Quality Control Associate:

  • Perform routine testing including ELISA, RODAC, and qPCR to ensure cGMP compliance
  • Operate routine environmental monitoring instruments
  • Responsible for general lab duties such as inventory, lab cleaning and instrument calibration
  • Follow established protocols and methods
  • Troubleshoot and support various test methodologies

Qualifications

  • Associate or bachelor’s degree in biology, chemistry, biochemistry, chemical engineering, biotechnology or related subject
  • Eagerness to learn and passion for the biotechnology industry
  • Collaborative and team-oriented
  • Detail-oriented
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Mechanical Design Engineer (CONTRACTOR)

Responsibilities

  • Follow design control requirements and create 3D models in SolidWorks or Pro E
  • Create assembly, detailed drawings (P&ID), specifications, design verification and validation plans, protocols and reports
  • Write and execute protocols including installation qualifications (IQ), operational qualification (OQ) and performance qualification (PQ)
  • Prepare engineering change requests, engineering change orders, bills of material, purchase specifications and technical documents for customer submittals.
  • Collaborate closely and effectively with cross-functional departments worldwide to drive project tasks to completion
  • Process development of new automation and hardware design. Candidate responsible for validation and testing of equipment and new technologies
  • Compose work instructions and provide training to stakeholders 

Education and Experience Requirements

  • BS degree in mechanical engineering or related degree and/or equivalent experience
  • 2+ years of experience in mechanical design role and use of SOLIDWORKS, AUTOCAD
  • Basic knowledge of regulatory requirements (ASME, UL, CE) and experience working with regulatory compliance processes
  • Excellent teamwork, coordination and communication skills
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Electrical Engineer, Life Cycle Engineering (CONTRACTOR)

Responsibilities

  • Design as well as sustain engineering activities and design changes on existing product. Tasks include system level architecture, control panel design (Electric Schematics, PLC firmware development), EMI/EMC design and mitigation, electronic component selection
  • Participate in all phases of new product development, including concept, architecture, documentation, design, prototype, test, supplier interfaces and manufacturing introduction
  • Analyze and solve quality issues, initiating sample build and lab testing, evaluating test samples, introduction and follow up of design changes in manufacturing
  • Verify product performance against design inputs. Write verification protocols, perform testing, analyze and interpret test data, and write and present verification reports
  • Maintains; schematics, assembly drawings and associated Bill-of-Materials, manufacturing documents, including initial assembly instructions, inspection specifications, and packaging instructions

Education and Experience Requirements

  • BS or Masters Degree in Electrical Engineering
  • An understanding of hardware engineering including knowledge of creating designs and implementation in hardware
  • Proficient in electrical CAD tools, develop electric schematics, wiring diagrams, wiring connection specifications and other related documents for manufacturing
  • Experience in designing products complying with international regulatory compliance including; RoHS, IPC, IEC and NEMA
  • Experience in PLC programming
  • Knowledge of Thermal aspects of electrical system design
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