Manufacturing Engineer I/II

Our world needs ideas! As one of the world’s most research-intensive chemical companies, Wacker has been developing leading solutions for numerous sectors – from construction to photovoltaics and cosmetics to rubber – for over 100 years. We have a global presence with production sites on three continents and 13,800 employees from 70 nations.

Wacker Biotech, as part of Wacker, is a leading global biotechnology organization specializing in the production of biopharmaceuticals. The company has outstanding technologies for the rapid, efficient and thus cost-effective production of therapeutic proteins for clinical and commercial supply. Currently it is the biggest dedicated microbial Contract Development & Manufacturing Organization (CDMO) in the world. Its four dedicated and fast-growing production sites are currently based in Germany (Halle and Jena), The Netherlands (Amsterdam) and The United States (San Diego, CA).

Our regional presence in the U.S. is focused on GMP-compliant manufacturing of plasmid DNA products up to 500L. The team has extensive experience up to phase III clinical supply and successfully released more than 100 GMP batches for advanced therapy applications. 

At our San Diego site, we are currently looking for a ​Manufacturing Engineer I/II​ to be a part of our growing team.

Job Responsibilities

Wacker Biotech is looking for a manufacturing engineer to perform upstream and downstream production activities in a cGMP manufacturing environment.Job Responsibilities include:

• Perform fermentation, MCB, MWCB, lysis, chromatography, and buffer preparation operations
• Assist with introducing new equipment design and process improvements.
• Assist with troubleshooting process and equipment
• Assist with writing and revising GMP documentation including batch records, deviation reports, and SOPs
• Provide support for calibration, maintenance and validation activities
• Support the manufacturing team in setting up and participate in the daily upkeep of the plant.
• Process data analysis.
• Generate equipment validation protocols and final reports.
• Pay attention to details, maintain accurate records and documentation, and adhere to safe manufacturing practices..

Qualifications

• Bachelors in Chemical or Biochemical Engineering or related discipline with a minimum of 6 months of experience in a manufacturing pharmaceutical/biotechnology environment. Master’s degree in Chemical or Biochemical Engineering or related discipline is preferred.
• Experience working with pilot- or commercial-scale processing equipment such as stirred-tank bioreactors, continuous-flow centrifuges, ultrafiltration skids, process tanks, and automated CIP/SIP systems;
• Experience working in a cGMP environment, including in-depth knowledge of current Good Manufacturing Practices, validation, process engineering, quality system regulations, and ISO standards;
• The ability to communicate clearly and precisely, both orally and in writing;
• Confidence, initiative, strong interpersonal and collaborative skills, and good personal organization skills;
• Ability to independently identify problems and effectively offer solutions to problems;
• Ability to work on multiple tasks simultaneously and meet project deadlines; and
• Experience working on cross-functional teams and a commitment to working in a fast-paced environment.
• Must be able to read and follow detailed instructions and possess good writing and verbal communication skills.
• Ability to work in a team environment is essential

WACKER, as an innovative chemical company, makes a vital contribution toward improving the quality of life around the world by developing intelligent solutions for sustainable growth. Our culture focuses on building and retaining diverse and inclusive teams. WACKER offers a great work environment, professional development, challenging careers, competitive benefit offerings and beyond through giving back to our communities.

Be part of our WACKER family, across all nations!

We are looking forward to your online application at www.wacker.com.
Reference Code: 23380 

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The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. A minimum requirement for this US-based position is the ability to work legally in the United States on a permanent unrestricted basis.  Visa sponsorship is not available for this position, including for any type of US permanent residency (e.g., for a Green card).

WACKER is proud to be an Equal Opportunity/Affirmative Action Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class.