Process Engineer II

Responsibilities

• Maintain all USP/DSP equipment and instruments to ensure continuous manufacturing with minimal downtime
• Lead the design, installation, and qualification of batch processing tanks, filtration systems, HVAC, and utility systems
• Support CAPEX projects for facility and equipment improvements to increase efficiency and reduce costs
• Provide technical guidance and support investigations for process-related deviations and change controls
• Create, execute, and document validation protocols (IQ/OQ/PQ) and write validation summary reports
• Troubleshoot automation systems, including programmed recipe fixing, changing, and testing
• Draft new SOPs, standard test procedures, master batch records, and other GMP-related documentation
• Update and maintain P&IDs and equipment drawings to reflect process changes

Requirements

• Bachelor's degree in a life sciences or engineering field
• Minimum 5 years of experience in pharmaceutical engineering or manufacturing
• Deep knowledge of cGMP, pharmaceutical manufacturing facilities, and large-scale equipment
• Proven experience with equipment qualification and validation (IQ/OQ/PQ)
• Strong ability to troubleshoot complex equipment and automation systems
• Proficiency in reading schematics, diagrams, and technical drawings
• Excellent written and oral communication skills for technical reporting and management updates

Preferred Qualifications

• Master's degree in a relevant engineering or life sciences field
• Background in automation systems software, such as DeltaV or FactoryTalk
• Experience with large-scale chemical reactors, solvent delivery systems, and purified water systems

Benefits

• Competitive base salary
• Annual performance bonus
• Comprehensive Medical, Dental, and Vision coverage
• 401(k) plan with employer contribution
• Paid vacation, personal, and sick days

About the Company

Bachem is a leading manufacturer of peptides and oligonucleotides. We take responsibility for future generations through careful resource handling and environmental stewardship, holding an EcoVadis Gold Medal status for our ecological performance.