Manufacturing Engineer, Downstream

3 months ago

Los Angeles, United States BioPhase Solutions Full time
Job DescriptionJob DescriptionBioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Manufacturing Engineer, Downstream to work for a leading Greater Los Angeles area biopharmaceutical company.
Salary: $120-140k+ depending on experienceResponsibilities:
  • Work in a team to support downstream and formulation operations for clinical viral vector production at scale
  • Safety and Compliance are the two primary objectives of manufacturing operations. Expected duties include the planning, execution and oversight of safe, compliant and efficient operation of area processes
  • Responsible for day to day planning and execution of all Downstream production operations as well as all related equipment and systems necessary to clean, configure, sanitize/sterilize and maintain equipment in a dynamic and fast-paced team environment.
  • Works in conjunction with other manufacturing technicians under the guidance of the team Lead
  • Expert knowledge on the principles and operations of downstream unit operations and related equipment such as:
    • Harvest, purification by means of column chromatography, filtration, TFF, depth filtration and buffer Preparation in small scale and pilot scale
    • Proficiency and routine maintenance of analytical equipment including but not limited to: pH/conductivity meters, filter integrity testers, peristaltic pumps and analytical equipment to support and monitor the process is required.
  • Experience with DeltaV Automation Systems and Unicorn System Control required.
  • Aseptic Processing experience required.
  • In-depth knowledge of quality systems, validation principles, regulatory/ICH guidelines and multi-product controls required.
  • Good Documentation Practices (GDPs), timely and effective written and oral communication of deviations, incidents, and/or safety concerns, and all relevant housekeeping duties to ensure the work areas are kept to a high level of cleanliness and inspection readiness.
  • Sets up and operates equipment in a classed clean room environment and completes all required paperwork using GDPs in a timely and accurate manner
  • Interacts with scientists, engineers, production staff and operational lead
  • May train junior staff in assigned area, and ensure that work is performed in accordance with quality standards and SOPs
  • May support deviation investigations, corrective action implementation and change management initiation
  • In-depth knowledge of quality systems, validation principles, regulatory/ICH guidelines and multi-product controls required.
  • Departmental representation as an SME (Subject Matter Expert) on cross-functional teams including Process Development, Quality Assurance and Control, Calibration, Maintenance, Validation, Supply Chain, and CMC/Regulatory teams is required.
  • Perform troubleshooting as necessary and takes initiative in resolving issues
Qualifications:
  • Requires a HS diploma and minimum 5 years of relevant industry experience, or a Bachelors degree in engineering or scientific discipline and minimum 3 years of industry experience.
  • Previous biotechnology experience in viral vector production or Purification manufacturing of monoclonal antibodies in a clinical or commercial environment is required.
  • Knowledge of Current Good Manufacturing Practices (cGMPs).
  • Prior experience initiating, owning and closing out deviations, change control, CAPA’s and safety improvement projects required.
  • Background or understanding of Lean concepts (5S, KanBan) desired
  • Background in disposable technology and multi-product facility desired
  • Good verbal, written, and interpersonal communication skills
  • Demonstrates ability and willingness to act both independently as well as with a team
  • Consistent positive attitude and demonstrated ability to learn new skills is very desired
  • Exhibits accountability, including taking ownership for words and actions and fulfilling commitments responsively.
  • Able to lift equipment up to 25 lbs.
Please send resumes to tiffany@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities

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