Manufacturing Engineer, Downstream
BioPhase Solutions
Los Angeles, CA
Manufacturing Engineer, Downstream
BioPhase Solutions
Los Angeles, CA
- $120 Hourly
- Full-Time
Job Description
Company Info
Job Description
BioPhase 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 experience
Responsibilities:
- 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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