Small Molecule Project Technical Lead - Catalyx

 Purpose of the Role:

The Small Molecule Technical Lead will be responsible for technically leading the Automation control system solution for the Small Molecule facility. They will work closely and in conjunction with the other members of the Small Molecule facility 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 Small Molecule project

•                     Technical management of the Small Molecule project system integrator

•                     Working closely with the Small Molecule Automation Project Manager to deliver the project on schedule successfully 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, 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

Requirements

Role Requirement:

•                     BS Engineering (or equivalent experience)

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

•                     Previous Small Molecule 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 audiences