Project Technical Lead- Development Laboratory & Support
CatalyxAbout 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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