Process Engineer II

About the role

The Process Engineer II supports, maintains, and optimizes large-scale upstream and downstream production equipment and instrumentation to ensure reliable, continuous manufacturing operations with minimal downtime. This role leads process improvement initiatives, designs and qualifies equipment, and provides recommendations to enhance efficiency and product quality.

Responsibilities

• Maintain all USP/DSP equipment and instruments at the ready-to-run status to ensure continuous manufacturing operations with minimal downtime
• Design, install, and qualify batch processing tanks, solvent recovery systems, filter dryers, filtration systems, ultra-low freezers, HVAC, solvent distribution and recovery systems, compressed air, purified water, and wastewater systems
• Support production on capital expenditure (CAPEX) projects for production facility and equipment improvements to increase efficiency and reduce costs
• Support large-scale production process development and optimization projects
• Provide technical guidance and support for process-related deviations, change control, and operational excellence projects
• Oversee implementation, commissioning, and qualification of USP/DSP facility and process equipment
• Maximize production operations success by instituting programs to minimize human error, mechanical failures, contaminations, and procedural errors
• Communicate operational status regularly to senior and corporate management, including through written documents and formal/informal oral presentations
• Create new process and equipment drawings based on specifications and standards
• Update and maintain drawings and P&ID to reflect changes to existing processes
• Troubleshoot process equipment and ensure it works to its specifications and capacities
• Create, execute validation protocols, and write validation summary reports
• Draft new procedures, SOPs, and protocols and train staff on these expectations
• Write technical reports to support process development data
• Develop standard operations procedures, standard test procedures, master batch records, and other related GMP documents

Requirements

• Bachelor's degree in a life sciences or engineering field
• Master's degree (preferred)
• Minimum 5 years of experience in 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, and utilities

Qualifications

• Excellent written and oral communication skills
• Proactive and solutions-focused communication with management
• Independent and time-management abilities
• Effective meeting scheduling and negotiation skills with vendors, contractors, and customers
• Detail-oriented with the ability to troubleshoot and resolve equipment and process problems and deviations
• Strong analytical and problem-solving skills
• Creative thinking skills with detail orientation
• Excellent manual dexterity

Skills

• Automation systems software, such as DeltaV and FactoryTalk, is preferred

Benefits

• Base Annual Salary Range: Engineer II: $83,089 - $114,247, Sr. Engineer: $102,331 - $140,705
• Total Rewards Package includes competitive pay, annual performance bonus, comprehensive medical/dental/vision coverage, 401(k) plan with employer contribution, and paid vacation, personal, and sick days

Placement

Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

Corporate Social Responsibility

Bachem takes responsibility for future generations by carefully handling resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees' environmental awareness.

EEO Statement

We are an Equal Opportunity Employer and celebrate the diversity of our team. We are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.