Job Description
Purpose of the Role:
The MESDV will lead/participate with the team to finalise the development of the communication modules, perform testing, and proceed with installation and verification. They will also support the process/operations team during process qualification.
The MESDV will report to the Automation Program Manager.
The MESDV will interface with Verification (Commissioning and Qualification), Construction Management, Design Leads, Process engineers and Operations.
Role Responsibilities
• Provide subject matter expertise for the sites MES to DeltaV interfaces.
• Technically Lead and oversee the work and work products produced by the team.
• Responsible for providing problem resolution and integration approaches to IT systems.
• Work collaboratively with the vendor Engineers and Developers.
• Lead/Participate in design reviews and application software reviews.
• Interacted regularly and provided formal and informal project status updates to project management.
• Abide by all safety requirements and procedures of their role.
Role Requirements:
• BS Engineering (or equivalent experience).
• Minimum 5 years as an engineer in a MES environment for pharmaceutical products (preferably Syncade)
• Minimum 5 years as an engineer in a DCS environment for pharmaceutical products (preferably DeltaV)
• They have demonstrated technical leadership and teamwork abilities.
• Experience in GMP, regulatory requirements, computer system validation, and cybersecurity.
• Good written and verbal communication skills for both technical and non-technical audiences.
Preferred attributes but not required:
• Experience with MES/DCS software application interfaces.
• Thorough knowledge/experience in cGMP, ICH, USP and other applicable regulations.