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Project Technical Lead- Development Laboratory & Support

Catalyx
United Statesfull_timeVerifiedPosted 23 Jan 2025

About the role

 Purpose of the Role:

The Technical Lead will be responsible for technically leading the Automation control system solution for the Development Laboratory and automation interfaces to support areas e.g Warehouse and Administration areas. They will work closely and in conjunction with the other members of the Project Team, including the Automation Project Manager, the Automation Area Leads, Process Engineers, Tech Services/Manufacturing Science Representatives, Quality Engineers, and Operations.

Role Responsibilities:

                     Technical ownership for the Development Laboratory and Support Areas project

                     Technical management of the Development Laboratory and Support Areas project system integrator(s)

                     Working closely with the Development Laboratory and Support Areas 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 work stream 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 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

                     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


Requirements

Role Requirement:

                     BS Engineering (or equivalent experience)

                     10+ years working Automation experience in the Pharmaceutical Industry (preferable in API/bulk manufacturing)

                     Previous Development Laboratory project or site experience

                     Previous Pharmaceutical Automation Large Project/Program experience/expertise

                     Experience with devices integration into automation and historian platforms

                     Preferable, a previous experience with DeltaV DCS

                     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

                    

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Company

Catalyx

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