- 01As a Process Engineer III on our Global MSAT Process Engineering team, you’ll
- 02play an important role in bringing new equipment and innovative technologies
- 03into our biologics manufacturing network.
- 04You’ll work cross-functionally with Manufacturing, MSAT, Automation, external
- 05vendors, and other key stakeholders to evaluate, design, test, procure, and
- 06implement new manufacturing technologies. You’ll also develop documentation
- 07supporting qualification and validation activities and provide technical and
- 08operational support across the Just-Evotec manufacturing network.
- 09This role offers the opportunity to take ownership of technical projects, solve
- 10complex manufacturing challenges, and help shape how new technologies are
- 11implemented in a GMP biologics environment.
- 12The role will also provide support at Just-Evotec and client sites, contribute
- 13to regulatory submission documentation, and support regulatory and site
- 14inspections.
What You'll Do
- 15Partner with key stakeholders and vendors to evaluate and implement new manufacturing technologies that improve efficiency and facility throughput.
- 16Develop technical design documentation, including User Requirement Specifications (URS) and software functional specifications, to support process, commissioning, qualification, and validation requirements.
- 17Collaborate with Automation on the design and development of Distributed Control Systems (DCS) and integration with manufacturing equipment.
- 18Support technical evaluations of facility and utility requirements for manufacturing equipment and technologies.
- 19Lead the evaluation of single-use technologies, including the design of single-use manifolds and assemblies.
- 20Partner with vendors to develop testing data and validation packages supporting new equipment and technologies.
- 21Support the procurement, implementation, qualification, and lifecycle management of approved manufacturing technologies.
- 22Develop business processes, guidelines, SOPs, training materials, and equipment maintenance and lifecycle plans.
- 23Lead or support non-conformance and deviation investigations and assess the process impact of equipment and technology-related issues.
- 24Facilitate the exchange of technical knowledge, challenges, and solutions across the manufacturing network.
- 25Participate in internal and external audits and regulatory inspections, as needed.
Who You Are
- 26BS in engineering, sciences, or related life science engineering 5+ years of relevant experience in Pharmaceutical, Biotech, or Life Sciences industries, or MS with 2+ years of experience.
- 27Strong knowledge of single-use processing equipment and technologies used in biopharmaceutical manufacturing.
- 28Experienced in leading technology implementation and validation activities for clinical and commercial manufacturing readiness
- 29Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics/pharmaceuticals.
- 30Solid understanding of monoclonal antibody processing, either at manufacturing scale or within process development.
- 31Experience working with single-use disposable manufacturing systems.
- 32Demonstrated ability to work independently and collaboratively on cross-functional teams.
- 33Working knowledge of manufacturing process equipment and automation systems.
- 34Candidate must focus on quality, attention to detail, and effective task/time management and organizational skills.
- 35Ability to organize, analyze/interpret, and effectively communicate process data.
- 36Excellent oral and written communication skills.
Additional Preferred Qualifications
- 37Experience with continuous manufacturing processes, DeltaV automation, and/or mentoring or guiding less-experienced engineers.
- 38Experience developing and executing Commissioning, Qualification, and Validation (CQV) plans and protocols.
- 39Can work independently and in project teams.
Why Join Us
- 40Growth Opportunities: We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow.
- 41Inclusive Culture: We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.
- 42Innovative Projects: You’ll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
- 43A Place for Big Ideas: We don’t just talk about thinking outside the box, we throw the box away. If you’ve got ideas, we want to hear them.
Are You Still Curious?
If you’ve read this far, then chances are you’ve got a curious mind, just like us. So, what are you waiting for? Take the leap and apply today. We can’t wait to see where your curiosity leads you and how it will shape the future of Just-Evotec Biologics.
Let your curiosity guide your career #BeCurious and explore the endless possibilities at Just-Evotec Biologics!
The base pay range for this position at commencement of employment is expected to be $92,400 to $126,500; Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
Estados Unidos
