Senior Production Engineer

Location
San Diego, CA
Posted
Jan 12, 2022
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

The ideal candidate for this role will have previous experience in manufacturing and a familiarity with basic laboratory procedures. This Senior Production Engineer role will be responsible for improving manufacturing quality, lead time and cost through active problem solving, developing solutions, and implementing process changes in accordance with the quality system. Attention to detail and the ability to author detailed reports are key to a successful candidate. We are looking for someone who has the dedication and focus to perform their tasks consistently, accurately, and with reproducible results. The candidate will report to the VP of Operations and will focus on production, inventory management, process improvement and quality control activities.

Responsibilities, but not limited to:

  • Be fully responsible for all internal Production related tasks and processes
  • Identify opportunities for improvements to the process and lead projects designed to implement those improvements
  • Prepare reagents and perform production related tasks per established Work Instructions
  • Design manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining, and material handling
  • Technical Transfer of new process steps and equipment. Apply GMP and GDP principles to assembly and test procedures and documentation. Perform Process Validation (IQ OQ PQ), Validation performance and Reports
  • Perform Design Verification, Validation, Process Validation and Test Method Validation
  • Perform process characterization studies with DOEs. Develop process improvements and design automation equipment and fixturing for hand assembly
  • Perform QA and QC to test products for functionality and quality. Measure and record data associated with QA and QC
  • Performing work order processing to complete products to inventory
  • Prepare production documents, such as standard operating procedures, manufacturing batch records, inventories, or productivity reports as needed
  • Use laboratory tools and skills to measure and quantify materials
  • Provide production, progress, changeover reports, or data analysis reports to supervisors
  • Provide technical training to operators and support staff
  • Identify problems, safety concerns and suggest improvements
  • Collect hazardous or non-hazardous waste in correctly labeled barrels or other containers and transfer them to collection areas, inform Lab manager when these containers are near full
  • Perform bench processes to complete mechanical, electrical, and optical assemblies using hand and electronic equipment
  • Receive, pack, and ship items as necessary
  • Maintain a clean and orderly work area

Qualifications:

  • Chemical, Mechanical, or similar engineering degree required. Master’s level is preferred
  • At least 3+ years of manufacturing experience including new process technology implementation and process optimization is required
  • Preferred experience with laboratory equipment including scales, pipettes, microscopes, pumps, ovens, and gas cylinders
  • Required, hands-on experience on drafting Protocols, Testing reports and Data Analysis
  • Lean Six Sigma or Six Sigma training and certification preferred
  • Experience in developing and implementing custom automated manufacturing equipment is highly desired
  • Experience with Microsoft Office 365 including Outlook, Word, Excel, PowerPoint
  • Experience with NetSuite is a plus
  • Excellent interpersonal skills, ability to work with a closely within a team as well as be able to interact with diverse members of the company at large
  • Superb written and verbal communication skills
  • Onsite in San Diego, CA