R&D Technician

  • location: Cambridge, MA
  • type: Contract
  • salary: $23.34 - $27.46 per hour
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job description

R&D Technician

job summary:




Manufacturing Technician IV

Job Summary

  • This position requires shift, weekend and holiday work.
  • Must be able to work in controlled unclassified environment requiring special gowning.
  • Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
  • No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments.
  • Inside working conditions.
  • Overtime may be required at times.
  • May be required to work or be assigned to a different shift as needed.
  • Must be able to work more than 8 hours a day or 40 hours a workweek as required.
  • Will have interaction with other people.
  • Pace may be fast and job completion demands may be high.
Job Responsibilities

  • ?Gowning and degowning for Packaging area.
  • Responsible for Room sanitization, wrapping up components, operating autoclave, performing CIP/SIP of tanks, small parts washing
  • Visual inspection of lyophilized product vials, Visual inspection of empty vials for glass defects, Visual inspection of empty vials for washout defects, visual inspection of rubber stoppers for defects
  • Clean and sanitize manufacturing and associated support areas.
  • Responsible for monitoring bioreactors and respond to alarms in all Cell Culture Suites.
  • Responsible for monitoring the skids and respond to alarms in all Purification Suites.
  • Record bioreactor, chart recorder readings, alarm response related to the bioreactor, skid performance, inoculums and emergency response during blackouts.
  • Conduct documentation review
  • Participate in Quality Working Teams and Continuous Improvement Teams
  • Conduct visual inspection of needles and assemble needle packs.
  • Operate pallet jack and shrink wrap
  • Manually clean equipment and conveyors.
  • Load/Unload materials to conveyors and packaging carousel.
  • Responsible for Biodecontamination and appearance of all Manufacturing Production areas, Bulk Formulation, Aseptic filling, Sterility Test room, Final Container Drying and Preparation Production rooms.
  • Prepare solutions in portable mixer.
  • Operate production equipment such as pH meter and autoclaves.
  • Monitor department equipment for proper operation.
  • Stock department supplies
  • Handling and Removal of Hazardous Waste
  • Intermediate Computer Skills
  • May perform safety and cGMP inspections or observations.
  • Ensure compliance with SOP/cGMP and cGDP requirements.
  • May assist in updated/revising SOPs.
  • Complete relevant paperwork following GDP/GMP guidelines.
  • Receive and distribute supplies into the production area as necessary.
  • Provide Critical process monitoring and trouble shooting.
  • Diagnosis equipment problems and implement corrective actions.
  • Conduct cGMP inspections/audits.
  • Initiate Work Requests.
  • Inventory Handling.
  • Train and mentor junior level technicians.
  • Work with other groups such as maintenance/metrology to ensure preventative maintenance is done.
  • Initiate and/or coordinate other process improvement projects.
  • Rewrite complex procedures or initiate new procedures as applicable.
  • Perform complex trouble shooting tasks and may even assist during the transfer of new technologies into manufacturing.
  • In Leadership focused roles, assist supervisor in organizing, scheduling and directing other team members.
  • In Technical focused roles, is the main interface with other departments to resolve issues related to equipment, process, compliance, including maintenance, metrology, and validation. Main troubleshooting/response person.
  • Ensure timely and accurate generation of process documentation. Investigate, Review and process documentation.
Education & Qualifications

  • Requires high school diploma with 2-4 years related work experience. Or AA degree with 1-2 years of related manufacturing experience.
  • Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
  • Knowledge of cGMP manufacturing and SOPs.
  • In-depth process knowledge of related manufacturing techniques and specialties.
  • In Leadership focused roles, must have demonstrated interpersonal and leadership skills and be able to lead a work team effectively and efficiently in a team environment.
  • Basic Knowledge of Cell Culture, Purification, and Formulation/Filling operations and capabilities.
  • Understands Manufacturing Production Process as it pertains to: Visual product integrity processes; Visual inspection of components, finished goods and imprinting; Manual and semi-automated packaging; Product labeling
  • Understands Manufacturing Production Flows for all product lines.
  • Understands the flow and design/interdependency of manufacturing support departments
  • Knowledge of clean room management.
  • Basic knowledge of microbiology.
  • Knowledge of inventory management.
  • Knowledge of manufacturing equipment operation, including set up and changeover, as well as commissioning, validation, and troubleshooting
  • Results oriented and possess the ability to work independently as well as within a team environment.
  • Must have the ability to correctly complete high school-level mathematics.
  • Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
  • Must be able to apply quantitative analysis to analyze process performance.
  • Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
  • Must be able to read, write, and converse in English.
  • Must be able to navigate, conduct searches, and fill on-line forms on Personal Computer for the purposes of training, performance management, and self-service applications.
  • Must have the ability to navigate electronic mail systems and intranet for communication purposes.
  • Must be self-motivated.
  • Must have Intermediate level computer skills
  • Good interpersonal skills and be able to work effectively and efficiently in a team environment.
  • Knowledge of basic chemical and biological safety procedures.
  • The incumbent must work in a controlled environment wearing special garments.
  • Additionally, personal protective equipment must be worn due to safety requirements.
  • Must have and display the following personal attributes: Integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
  • Must demonstrate the following shared values: Must have passion to innovate and drive for solutions, must display personal accountability for results and integrity, must have uncompromising dedication to quality, must have relentless focus on rapid and disciplined action, must have personal accountability.
  • Must have and display the following Leadership Expectation competencies: Critical Thinking and Problem Solving, Communication, Business Acumen, Collaboration and Teamwork, Motivating and Developing Others, Dealing with Ambiguity and Customer Focus.
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance


 
location: Cambridge, Massachusetts
job type: Contract
salary: $23.34 - 27.46 per hour
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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