Manufacturing Engineer I

Join the Teknova Team and Help Shape the Future of Health

When you join the Teknova team youre helping to create the future of health. Our customers are working to discover novel therapies that will help people everywhere live longer healthier lives. We make sure they have a reliable supply of the essential ingredients they need to succeed and every member of our team plays an important role.

JOB OVERVIEW

The Manufacturing Engineer I supports manufacturing operations through process optimization continuous improvement initiatives troubleshooting and implementation of industrial and automated systems asset management activities and compliance driven manufacturing support. This role partners closely with Operations Quality Facilities and other cross-functional teams to improve operational efficiency product quality and manufacturing performance. This position reports to the Manufacturing Engineering Manager.

Our Culture:

At Teknova our culture is all about creative problem solving and our default answer is Yes. Were customer-obsessed and go all in for them and each other. We arent interested in the status quowe want to discover whats possible. Were bold and built to change. We go above and beyond to develop novel products that help our customers get reliable results engineer formats that fit their systems and find ways to ship out their orders one day sooner. Every time we help our customers work more efficiently; we bring them a step closer to that big breakthrough.

Our Values:

We value the unique personality and background of everyone on our teamwe want you to be you. By working together and sharing our skills we find new and better solutions for our customers. The people on our team are at the heart of everything we do and were here to support them.

JOB DUTIES AND RESPONSIBILITIES

• Develop and implement manufacturing process solutions to address operational capability gaps including optimization of existing equipment and evaluation specification or procurement of new equipment as needed.
• Support day-to-day manufacturing operations by troubleshooting manufacturing industrial and/or automated equipment issues to minimize downtime and maintain operational efficiency.
• Develop revise and maintain Standard Operating Procedures (SOPs) work instructions process documentation and engineering records.
• Support continuous improvement initiatives utilizing lean manufacturing root cause analysis and data-driven problem-solving methodologies.
• Participate in deviation investigations CAPA activities nonconformance reviews and process improvement projects.
• Collaborate with Mechanical Process and Quality Engineering for the creation and execution of validation documents (RTM CP IOPQ etc.) as well as data generation and report generation.
• Develop and maintain project schedules status reports and implementation plans using project management tools.
• Maintain accurate equipment and asset records within the companys asset management system.
• Track equipment lifecycle activities including installation maintenance history calibration status repairs upgrades and replacement planning.
• Assist in developing standardized asset management procedures and equipment documentation.
• Support manufacturing readiness activities for new products process and/or equipment changes or scale-up initiatives.
• Ensure compliance with GMP requirements company procedures and applicable regulatory standards.
• Communicate project status risks and timeline impacts to management and key stakeholders.

EDUCATION

• Bachelors degree in Engineering (Manufacturing Engineering Industrial Engineering Mechanical Engineering) Life Sciences or related technical discipline.
• 2 - 4 years of manufacturing or engineering experience preferred.

KNOWLEDGE / SKILLS / EXPERIENCE

• Strong understanding of manufacturing processes industrial equipment and continuous improvement methodologies.
• Hands-on troubleshooting experience with automated manufacturing equipment and production systems preferred.
• Ability to diagnose and resolve mechanical electrical pneumatic and process related manufacturing issues.
• Familiarity with industrial automation systems equipment controls sensors and manufacturing support systems preferred.
• Understanding of GMP requirements and regulated manufacturing environments preferred.
• Strong analytical and root cause investigation skills with the ability to interpret technical data and develop effective corrective actions.
• Effective verbal and written communication skills.
• Understanding of equipment lifecycle management preventive maintenance strategies and equipment reliability concepts.
• Strong communication and cross-functional collaboration skills in a fast-paced manufacturing environment.