Senior Automation Engineer - Singapore - PROJECT DELIVERY PARTNERS PTE. LTD.

Description

Primary Tasks & Responsibilities

Responsible for leading Pharma and Biopharma projects using DeltaV System with batch design

(CM, EM, Phase, Recipe, etc).

• Responsible for design & manage interfaces to third party PLC systems with DeltaV.

• Responsible for managing internal stakeholders and coordination with various system vendors.

• Responsible for reviewing vendor functional specifications and design specifications and ensuring these are aligned with client global and local standards.

• Work with various teams to design system architecture, network architecture, cable schedule.

• Responsible for reviewing test documents and protocols (FAT, SAT, Interface Test, etc.) so that they meet CSV and QA standards.

• Responsible for participating in design meetings at various vendor locations.

• Responsible for witnessing FAT's and interface test at various vendor locations.

• Work closely with qualification teams to support qualification test generation and execution efforts in IQ, OQ and PQ.

• Support FAT, SAT, IQ, OQ andPQ.

Required Experience & Knowledge

• 10+ years of experience in executing DeltaV Pharma & Biopharma Batch projects.

• Extensive knowledge of DeltaV Batch is required.

• Understanding of S88 standard is required.

• Good understanding of the vaccine manufacturing processes or similar such processes is required.

• Understanding of PLC systems like Siemens, Schneider, Rockwell with some prior execution experience in interfacing these systems to DeltaV is required.

• Experienced in developing automation design philosophies, test plans, protocols and quality reports.

• Experienced in developing automation URS, FS, DS from process writeups and tech transfer documents.

• Proficiency in written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with other stakeholders.

Soft Skills

• Coaching and communication skills.

• Good knowledge in coordination of activities.

• Must be willing to travel for meetings, and FATs at vendor locations.

• Autonomous.

• Proactive, self-starter and capable of working alone or in a team environment.

• Ability to interpret and operate within defined schedules managing available resources to achieve project milestones.

• To be aware and supportive of the project's requirement for flexibility in working hours/shift patterns through the differing phases of the project's life cycle.

• Experience with Quality Change Control is desirable.

• Ability to work in project teams in a multidisciplinary environment.

Regulations and standard guidelines:

• Good expertise in the following Standards.

o cGMP o GAMP o GDP

o FDA (GxP)

o 21CFR Part 11

o ANSI/ISA88 Batch Control Standards

o Specific regulations and guidelines applicable to the pharmaceutical industry

Education, Methodology & Certification Requirements

• Degree in Engineering or Science discipline. Preferably in Electrical Engineering, Computer

Science/Information Technology, or Chemical/Biochemical/Mechanical Engineering.

• MS Office.