Manufacturing Engineer II: Process Readiness & Validation

Aequor; Warsaw (IN); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

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Job summary

Aequor is seeking a Manufacturing Engineer to support process readiness, transfers, validations, and changes across manufacturing operations. You will develop instructions, review ECR/ECN, and ensure compliance with QA and regulatory requirements.

You will work with Windchill and InfoPV to manage documentation, qualification activities, and control plans, driving efficiency and manufacturability improvements.

Qualifications

• Demonstrated working knowledge of the InfoPV system and traceability.
• Strong hands-on Windchill knowledge with engineering docs and change management.
• Knowledge of equipment qualification/validation (IQ/OQ/PQ) and requalification.
• Experience with cleaning validation principles and documentation.
• Experience with packaging validation, seal validation, package integrity and aging studies.
• Experience with process changes, documentation, cross-functional implementation.
• Hands-on proficiency with process transfers, upgrades, Gage R&R, control plans, Vault DMR updates.

Responsibilities

• Own and review ECRs, ECNs, routers, BOM updates, and work instructions.
• Walk processes to assess readiness, risks, and implementation needs.
• Support equipment installation, qualification (IQ/OQ/PQ), requalification, validation, relocation, and decommissioning activities.
• Support cleaning validation and process development, including acceptance criteria and sampling methods.
• Support packaging validation: integrity, seal strength, sterile barriers, distribution and aging studies.
• Assist with protocol creation, execution support, deviation resolution, and report activities tied to transfers, validations, and manufacturing changes.
• Use Windchill to author, review, manage, and support engineering documentation and change activity.
• Own and execute InfoPV equipment qualification and validation activities, including protocol setup, documentation, execution support, record management, and traceability within the system.
• Develop, review, and maintain control plans, process flow diagrams, and pFMEAs to ensure manufacturing process consistency and compliance.
• Partner with Operations and Quality to improve flow, efficiency, and manufacturability.

Skills

InfoPV

Windchill

IQ/OQ/PQ

Cleaning validation

Packaging validation

Process changes

Gage R&R

Education

Bachelor's degree in Mechanical/Biomedical/Manufacturing/Industrial engineering

Job description

Aequor is seeking a Manufacturing Engineer to support process readiness, transfers, validations, and changes across manufacturing operations. You will develop instructions, review ECR/ECN, and ensure compliance with QA and regulatory requirements.

You will work with Windchill and InfoPV to manage documentation, qualification activities, and control plans, driving efficiency and manufacturability improvements.