OEM Engineer

OEM Engineer

Key Responsibilities:

Participate in the development review and approval of project SDLC documentation and deliverables.

Integrate OEM systems with site DCS (DeltaV) and SFN subsystems (PM Server Octoplant Simatic Logon time sync. etc) ensuring compatibility and functionality.

Execute validation and qualification automation test protocols (EIOC AIOQ ACP) to ensure the reliability and compliance of integrated systems.

Serve as a subject matter expert (SME) in Siemens S7 PLC and HMI systems providing guidance and support to project teams.

Offer technical assistance to CSV & DDQ teams ensuring adherence to regulatory requirements and industry standards.

Provide ongoing technical support to Manufacturing Operations troubleshooting issues and optimizing system performance.

Collaborate with crossfunctional teams to identify opportunities for process improvement and innovation.

Stay abreast of industry trends technologies and best practices to continuously enhance knowledge and skills.

Qualifications:

Bachelors degree in Engineering Computer Science or related field.

5 years of experience in a similar role preferably in a GMP regulated environment.

Proficiency in Siemens S7 PLC and HMI systems with demonstrated expertise in integration and troubleshooting.

Experience with DeltaV PAS and other relevant subsystems.

Strong understanding of project SDLC processes and documentation.

Experience with validation and qualification of automation systems.

Knowledge of regulatory requirements such as FDA GMP and GAMP.

Excellent communication skills with the ability to effectively collaborate with crossfunctional teams.

Detailoriented with strong problemsolving abilities.

Ability to work independently and manage multiple priorities in a dynamic environment.

Familiarity with CSV (Computer System Validation) and DDQ (Data Integrity and Data Quality) processes.