Process Engineer II

Bachem AG•Vista, CA

43d•$83,089 - $114,247

About The Position

The Process Engineer II is responsible for supporting, maintaining, and optimizing large‑scale upstream and downstream production equipment and instrumentation to ensure reliable, continuous manufacturing operations with minimal downtime. Leveraging strong process mapping and analytical skills, this role leads the development and execution of process improvement initiatives, conducts engineering design evaluations, and identifies opportunities to enhance efficiency and product quality across USP/DSP processes. In addition, the Process Engineer II evaluates equipment needs, researches potential solutions, and provides informed recommendations to management. The role also partners closely with third‑party contractors to ensure timely completion of IQ/OQ/PQ activities. Strong independent troubleshooting capabilities are essential.

Requirements

Bachelor's degree in a life sciences or engineering field
Minimum 5 years of experience of pharmaceutical engineering and/or manufacturing
Thorough understanding of engineering fundamentals
Deep knowledge of cGMP, pharmaceutical manufacturing facility, large-scale equipment, and engineering principles
Good understanding of computer programming and software development
Ability to troubleshoot equipment problems and perform complex system tests.
Technical knowledge of USP/DSP processes / equipment / automation / utilities (e.g. large-scale chemical reactor, cleavage vessel, deprotection vessel, solvent delivery system, agitator, batches processing, tank, filtration, purified water system, heat exchanger, HVAC, etc.)
Equipment Qualification and Validation IQ /OQ / PQ and 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
Ability to schedule and host internal/external meetings and negotiate with vendors, contractors, and customers for the best interest of the production department. Excellent computer knowledge, including Microsoft Word and Excel
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 and process problems and deviations
Strong analytical and problem-solving skills.
Proficient in reading schematics and diagrams as well as other written materials
High level of safety awareness.
Creative thinking skills with detail orientation.
Excellent manual dexterity.

Nice To Haves

Master's degree (preferred)
Good background for Automation systems software, i.e. DeltaV and FactoryTalk, is preferred.

Responsibilities

Maintain all USP/DSP equipment and instruments at the ready-to-run status to ensure that manufacturing is continuously in operation with minimal downtime
When needed, be responsible for design, installation, and qualification of batch processing tanks, solvent recovery system, filter dryers, filtration system, ultra-low freezers, HVAC, solvent distribution and recovery system, compressed air, purified water, and wastewater system
Ability to learn the automation system trouble shooting including a programed recipe fixing, changing and testing.
Support production on CAPEX projects for production facility and equipment improvements in order to increase production efficiency and reduce cost
Perform activities associated with the design and qualification of the new and existing USP/DSP equipment used in a manufacturing plant
Support large-scale production process development and optimization projects
Provide technical guidance and support investigations for process related deviations, change control and operational excellence projects
Oversee implementation, commissioning, and qualification of USP/DSP facility and process equipment
Maximize the success rate for production operations by instituting programs to minimize human error, mechanical failure, contaminations, and procedural error
Maintain a safety-first approach in the large-scale manufacturing workplace
Communicate operational status regularly to senior management and corporate management, as required and appropriate. Communications include written documents and formal / informal oral presentations
Maintain a high level of compliance and efficiency to drive the organization to world-class manufacturing standards
Create new process and equipment drawings to existing processes based on specifications and standards
Update and maintain drawings and P&ID to reflect changes to existing processes
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
Write technical reports to support the process development data.
Write standard operations procedures, standard test procedures, master batch records, and other related GMP documents.