Sr. Process Engineer

Bachem Holding AG; Vista (CA); On-site; USD 102,000 - 141,000; Full time

Job summary

An innovative company is seeking a Senior Process Engineer to lead the design and implementation of manufacturing processes. This role involves collaborating with cross-functional teams to enhance production efficiency and ensure compliance with industry standards. The ideal candidate will have extensive experience in engineering design, project management, and troubleshooting within a fast-paced environment. Join a forward-thinking organization committed to quality and sustainability, where your contributions will drive significant advancements in the pharmaceutical and biotechnology sectors.

Benefits

Annual performance bonus

Comprehensive Medical/Dental/Vision coverage

401(k) plan with employer contribution

Paid vacation

Personal and sick days

Qualifications

• 7+ years of experience in engineering and project management.
• Knowledge of cGMP and FDA regulations.
• Experience with hazardous materials and chemical processes.

Responsibilities

• Design and implement manufacturing processes and systems.
• Lead technical activities for new production lines.
• Collaborate to streamline production processes.

Skills

Engineering Design

Project Management

Troubleshooting

Communication Skills

Process Development

Hazardous Materials Handling

Regulatory Compliance

Education

Bachelor’s degree in Engineering

Tools

HPLCs

Lyophilizers

Filtration Systems

Batch Processing Tanks

Solvent Recovery Systems

Job description

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Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com .

A brief overview

The Sr. Process Engineer is responsible for plans, design, development, implementation, and analysis of technical products, manufacturing processes and systems in an industrial plant with consideration of safety. Performs engineering design evaluations. Recommends alterations to development and design to improve quality of products, process and/or procedures. Maximizes efficiency by analyzing layout of equipment, workflow, assembly methods, and work force utilization. Determines parts and tools needed in order to achieve manufacturing goals according to product specification. Lead project team and drive project milestones to design, develop, project, and improve processes materials flow

What you will do

• Responsible for Design, installation, and qualification of batch processing tanks, solvent recovery system (Linde), filter dryers, HPLCs, filtration system, Lyophilizers, ultra-low freezers, HVAC, solvent distribution and recovery system, compressed air, purified water, and wastewater system
• Lead technical activities associated with the development and qualifications of new production line and equipment
• Collaborate with Production and Controls Team to develop and streamline production process in automating the new and existing system by harmonizing and leveraging developed technology.
• Develop and train cross-functional team members on utilization and maintaining new equipment and system – by creating roadmap, improving existing process, creating new procedures, job aids, SOPs and protocols as well as training of staff for these expectations
• Lead and support site development and production capacity expansion efforts
• Develop process and provide guidance for to improve engineering and project programs
• Troubleshoot process equipment, and monitor and trend to ensure that equipment works to its specifications and appropriate capacities
• Perform process development and performance trending studies for new and existing equipment and system in support of the site preventive maintenance and continuous improvement effort
• Lead engineering team and coordinates engineering activities to design, develop, and execute strategic investment projects, and improve process material flow
• Lead activities to design new processes, modify existing designs, improve production techniques, and develop test procedures
• Implement new technologies and process automation to improve production and operational efficiency
• Ensures compliance of company policies, procedures and objectives regarding processes, initiatives, and projects
• Oversee the design and construction of new plants
• Troubleshoot process equipment and ensuring that equipment works to its specifications and appropriate capacities

Qualifications

• Bachelor’s degree in engineering related field
• Minimum of 7 years’ relative work experience
• Experience in handling hazardous materials and chemicals
• Working Knowledge of ASTM and ASME BPE Standards and Industry Code as it relates to chemical, pharmaceutical, or related facilities
• Working Knowledge of cGMP, GDP, GEP engineering principles
• Knowledge of CalOsha Title 8, California Building Code (CBC), AQMD & APCD rules, and FDA title 21
• Technical knowledge of processes, equipment and utilities (batch processing, tank, filtration, lyophilization, purified water systems etc.)
• Successful track record in design, planning and project management of manufacturing or pilot plant facility expansions
• Handle complete project life cycle from design, planning and implementation to validation including master site planning and funding package development
• Excellent written and oral communication skills
• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
• Detail oriented with the ability to troubleshoot and resolve problems.
• Ability to work independently, manage one’s time, and function well in a team environment
• Ability to communicate effectively in a proactive and solution-focused manner, including keeping management aware of potential issues

Base Salary Range:$102,309 - $140,675

Placement in this wage range is based on several factors, including education, skill set, experience, and training.

Total Rewards

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

Corporate Social Responsibility

Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

As an equal opportunity employer, we celebrate the diversity of our team and 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.

Please note: unsolicited resumes from recruitment agencies will not be considered.