Senior Automation Engineer

Found in: Talent SG 2A C2 - 2 weeks ago


Singapore PROJECT DELIVERY PARTNERS PTE. LTD. Full time
Roles & Responsibilities

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.


Tell employers what skills you have

Coaching
Pharmaceutical Industry
FDA
Technical Writing
Manufacturing Processes
GAMP
Soft Skills
PLC
MS Office
Automation Design
Network Architecture
Communication Skills
Change Control
System Architecture
Electrical Engineering

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