Automation Biologics Engineer - Catalyx

Catalyx is seeking a Biologics Lead to join our team full-time and work on our customer site in Lebanon Indiana.

Who We Are:

Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyx’s partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company's experience and comprehensive suite of capabilities and solutions, visit www.catalyx.ai.

The Role:

Catalyx is a trusted partner in delivering world-class lifecycle services to regulated and high-risk end markets. With a relentless commitment to innovation and excellence, we partner with life science and other highly regulated organizations, to empower them to enhance efficiency, and drive success. As part of this commitment, we are continuously developing our on-site teams to support the advancement of customer operations.

The Biologics Technical Lead will be responsible for technically leading the Automation control system solution for the Biologics facility. They will work closely and in conjunction with the other members of the Biologics facility Project Team, including the Automation Project Manager, the Automation Area Leads, Process Engineers, Tech Services/Manufacturing Science Representatives, Quality Engineers, and Operations.

Responsibilities:

• Technical ownership for the Biologics project.
• Technical management of the Biologics project system integrator.
• Working closely with the Biologics Automation Project Manager to successfully deliver the project on schedule and budget.
• Collaborate with Program technical offices to ensure the automation solution is aligned with the overall program automation philosophy and standards.
• Collaborate with their Digital/MES workstream counterpart leads to align the automation and digital solutions.
• Provide technical leadership to the multiple area leads working on their project for the respective area and ensure that applicable standards are followed.
• Ensure consistency of the automation deliverables (requirements, functional specifications, control strategies, phases, and recipes, etc.).
• Participate in P&ID and control strategy reviews.
• Assist in defining the software components that need to be created or modified.
• Communicate progress, issues, and needs to automation project manager for the area.
• Provide input, review, and approve functional requirements and specifications.
• Support creation of Parameter and Recipe Specification documents.
• Responding to system integrator technical queries.
• Support the development of software testing strategies.
• Identification of any remediation effort required on process control software.
• Create items in the issue tracker as issues arise after the software acceptance.
• Identify and analyze risks of technical nature particular to the area and planning responses.
• Maintain compliance with training requirements.

Skills and Experience:

• BS Engineering (or equivalent experience).
• 10+ years working Automation experience in the Pharmaceutical Industry (preferable in API/bulk manufacturing).
• Previous Biologics Manufacturing project or site experience.
• Previous Pharmaceutical Automation Large Project/Program experience/expertise.
• 7+ years’ experience in DeltaV Batch DCS.
• Preferable, a previous experience with Allen-Bradley PLCs.
• Exceptional teamwork abilities.
• Strong knowledge of GMP’s, regulatory requirements and computer system validation principles.
• Excellent written and verbal communication skills for both technical and non-technical audiences.
• Strong knowledge of GMP’s, regulatory requirements and computer system validation principles.
• Excellent written and verbal communication skills for both technical and non-technical.

Why Join Catalyx?

Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone.

At Catalyx, we are committed to attracting the best global talent.