Pharmaceutical Systems Engineer

Position : Pharmaceutical Systems Engineer

Location : Indianapolis, IN (Onsite)

Experience : 3+ years

Industry : Pharmaceutical Manufacturing

Employment Type : Contract 12+ months

Overview :

We are seeking a skilled Pharmaceutical Systems Engineer to join its Indianapolis team. This role is crucial for advancing digital transformation initiatives by implementing and optimizing MES to improve production efficiency and ensure compliance.

Key Responsibilities :

Design, develop, and integrate MES components to support manufacturing operations.

Collaborate with cross-functional teams to translate business requirements into technical solutions.

Develop and maintain interfaces between MES and other enterprise systems.

Support startup and commissioning of MES solutions, ensuring alignment with operational needs.

Maintain comprehensive documentation throughout the MES lifecycle, following validation and release management protocols.

Evaluate emerging technologies and assess their impact on existing systems and operations.

Promote operational excellence and continuous improvement within the team.

Key Skills :

MES platforms such as Syncade, PharmaSuite, Werum PAS-X, or similar

System integration (ERP, SCADA, PLC, LIMS)

Troubleshooting and configuration

Documentation and CSV

GAMP 5, 21 CFR Part 11, Annex 11

Authoring and validating Master Batch Records (MBRs)

Continuous improvement and operational excellence

Working effectively in cross-functional teams

GMP compliance

Preferred Experience :

3+ years working with MES in pharmaceutical or life sciences environments

Strong communication and collaboration skills

Problem-solving mindset and proactive approach

Understanding of regulatory requirements and CSV principles