Automation Lead

Xyntek Inc.; Indianapolis (IN); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player seeks an Automation Area Lead to oversee control system solutions for innovative GMP clinical trial facilities. This role involves collaboration with a skilled project team to ensure alignment with automation standards and user requirements. The ideal candidate will have extensive experience in the pharmaceutical sector, particularly in automation for bulk manufacturing. Join a forward-thinking company where your expertise will drive operational efficiency and compliance in groundbreaking projects. If you're passionate about automation and thrive in a dynamic environment, this opportunity is for you.

Qualifications

• 8+ years of automation experience in the pharmaceutical industry.
• Strong knowledge of GMPs and regulatory requirements.

Responsibilities

• Technical ownership for an area in a project.
• Define S88 software structure and develop functional design specifications.
• Collaborate with project team to ensure automation solution alignment.

Skills

Automation Experience

DeltaV Batch DCS

Allen-Bradley PLCs

GMP Knowledge

Regulatory Requirements

Communication Skills

Job description

Indianapolis, United States | Posted on 04/23/2025

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.

Job Description

Minimum 1 week a month in Indiana during the basic/detailed design phase of the project. Full-time on-site during the commissioning phase of the project.

Constructing multiple standalone, highly flexible GMP clinical trial drug substance facilities on a greenfield site, which also includes site infrastructure, utilities, administrative offices, laboratories, and warehousing. The clinical trial facilities on the site will produce drug substances for small molecules, biologics, and nucleic acid therapies. The overall project is in the Basic Engineering design phase.

Purpose of the Role:

The Automation Area Lead will be responsible for the control system solution for an area within a project, ensuring the solution is aligned with the overall program automation philosophy, standards, and user requirements. The area lead will work in conjunction with the other members of the project team, including the Automation Project Manager, Automation Technical Lead, Automation Area Leads, Process Engineers, Tech Services/Manufacturing Science Representatives, Quality Engineers, and Operations.

Role Responsibilities:

• Technical ownership for an area in a project
• Define the S88 software structure and list for the area
• Develop draft functional design specifications for the area
• Work with system integrators to finalize the functional specifications
• Participate in P&ID and control strategy reviews
• Work closely with the Project Technical Lead and System Integrator 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
• Ensure consistency of the automation deliverables in the area (requirements, functional specifications, control strategies, phases, and recipes, etc.)
• Assist in defining the software components that need to be created or modified
• Communicate progress, issues, and needs to the automation technical lead for the project
• Provide input, review, and approve functional requirements and specifications
• Develop Parameter and Recipe Specification documents
• Respond to system integrator technical queries
• Identify any remediation efforts required on process control software
• Create items in the issue tracker as issues arise after software acceptance
• Identify and analyze risks of a technical nature particular to the area and plan responses
• Maintain compliance with training requirements

Requirements

Role Requirements:

• 8+ years of automation experience in the pharmaceutical industry (preferably in API/bulk manufacturing)
• Previous pharmaceutical automation large project/program experience/expertise
• 5+ years’ experience in DeltaV Batch DCS
• Preferable, previous experience with Allen-Bradley PLCs
• Exceptional teamwork abilities
• Strong knowledge of GMPs, regulatory requirements, and computer system validation principles
• Excellent written and verbal communication skills for both technical and non-technical audiences