All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status
Bachem Americas, Inc.
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 Process Engineer is responsible for supporting and maintaining all large-scale USP/DSP (Upstream Production / Downstream Production) equipment and instruments to ensure the manufacturing process is continuously in operation with minimal downtime. Through process mapping and understanding, the process engineer is responsible for developing process improvement projects, performing engineering design evaluations, creating efficiency in the USP/DSP process, and improving quality of product. The process engineer will not only account for identifying and researching background for equipment purchases and making recommendations to management. In addition will play a key role working with third party contractors to ensure the process IQ/OQ/PQ on a timely manner The independently troubleshooting capability is required.
What you will do
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 waste water 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 require 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.
Qualifications
Bachelor's degree in mechanical, electrical, chemical engineering, or related field
Master's in mechanical, electrical, chemical engineering, or related field (preferred)
Minimum of 1 year of experience in pharmaceutical engineering and 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.
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.
Good background for Automation systems software, i.e. DeltaV and FactoryTalk, is preferred.
Creative thinking skills with detail orientation.
Excellent manual dexterity.
Base Salary Range:
Process Engineer I: $68,000 - $94,000 (1-3 years exp)
Process Engineer II: $80,000 - $110,000 (3-5 years exp)
Placement of new hires in this wage range is based on several factors including education, skill sets, 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 Platinum Medal status in their assessment of Bachem.
Bachem Americas is an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status
