Process Engineer

Company: Bachem
Location: Torrance
Posted on: May 12, 2022

Job Description:

The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.Bachem. Leading Partner in TidesIn order to continue our organic growth, we are constantly looking for talent.Your ResponsibilitiesA process engineer is responsible for supporting and maintaining critical and supporting equipment and instruments to ensure the manufacturing process is continuously in operation with minimal downtime. Concurrently, through process mapping, the process engineer is responsible to develop process improvement projects to create efficiency in the process. The process engineer will also be responsible for identifying and researching background for equipment purchases and making recommendation to management.Your Tasks

• Support the Director on capital projects for facility remodeling and expansion
• Perform activities associated with the design and qualification of the new and existing equipment used in a manufacturing plant
• Lead the process development, optimization and scale-up of lyophilization processes to cGMP and FDA-compliant
• Oversee implementation, commissioning, and qualification of clean room spaces and process equipment
• Ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized to ensure uninterrupted supply of products produced
• Maximize the success rate for production operations by instituting programs to minimize human error, mechanical failure, contaminations, and procedural error
• Support strategic plans for process and plant improvements in order to increase efficiency and manage costs.
• Maintain a safety first approach to process development and manufacturing
• Communicate operational status regularly to senior management and to corporate management, as required, at the appropriate level of detail. Communications will be both written documents, and in formal and informal oral presentations.
• Maintain a high level of compliance and efficiency to drive the organization to world-class manufacturing standards
• Write design qualifications for qualifying batch processing tanks, reactors, filter dryers, HPLCs, filtration system, lyophilizers, cold rooms, ultra-low freezers, HVAC, compressed air, and purified water
• Create new process and equipment drawings to existing processes based on specifications and standards
• Update drawings and P&ID to reflect changes to existing processes
• Maintains drawing files (CAD, P&ID Diagram, PDF, and hard copies)
• Responsible for trouble shooting and providing corrective action directives
• Troubleshoot process equipment and ensuring that equipment works to its specifications and appropriate capacities
• Create, execute validation protocols and write validation summary reports
• Draft of new procedures, SOP's and protocols as well as training of staff for these expectations
• Perform process development studies for new and existing projects
• Write summary reports to support the process development data
• Write standard operations procedures, standard test procedures, master batch records and other related GMP documentsYour Profile
  • BS degree in Mechanical, Electrical, Chemical, Manufacturing Engineering or a Science related field
  • 3+ years of experience in engineering within a pharmaceutical manufacturing operation
  • Specific knowledge of cGMP, pharmaceutical manufacturing methods and engineering principles
  • Understanding of engineering fundamentals
  • Technical knowledge of processes/equipment/utilities (e.g. batches processing, tank, filtration, lyophilization, purified water system, HVAC, etc.)
  • Equipment Qualification and Validation IQ/OQ/PQ, SOPs
  • Excellent written and oral communication skills
  • Ability to communicate in a proactive and solutions-focused manner, including keeping management aware of potential issues
  • Ability to work independently and manage one's time
  • Basic computer knowledge, including Microsoft Word and Excel (used daily)
  • Communicate effectively and ability to function well in a team environment
  • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
  • Detail oriented with the ability to troubleshoot and resolve equipment problems.
  • Strong analytical math and problem solving skills
  • Proficient in reading schematics and diagrams as well as other written materials
  • High level of safety awarenessCandidates for positions as US employees of Bachem Americas, Inc. ("Company") must be in the process of or fully vaccinated against the COVID-19 virus and provide the Company with proof of vaccination as a condition of employment, except for U.S. employees who request and qualify under applicable law for disability and religious accommodation from the COVID-19 vaccine mandate. An applicant who receives an offer of employment from the Company for a position as a U.S employee will be required to provide proof of vaccination status, or request and receive a disability or religious accommodation for which the applicant is entitled under applicable law, before their first day of employment or any later deadline specified by the Company in the offer letter. The Company is an equal opportunity employer and provides employment opportunities and makes employment decisions without regard to an individual's disability, religion or on any other basis prohibited by law.

Keywords: Bachem, Torrance , Process Engineer, Other , Torrance, California