Manufacturing Engineer II

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

Position Summary

The Manufacturing Engineer supports process readiness, process and product transfers, engineering changes, equipment activities, validation execution, work instruction development, and manufacturing system implementation to ensure efficient and compliant site operations.

Key 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 cleaning process development, including residue and cleanliness acceptance criteria, sampling and test method selection, cleaning agent evaluation, worst-case/bracketing rationale, and periodic revalidation.
• Support packaging validation activities, including package integrity, seal strength and seal process validation, sterile barrier system qualification, distribution/transit simulation, shelf-life and aging studies, and labeling verification.
• 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

Required Qualifications & Competencies

• Required: Demonstrated working knowledge of the InfoPV system, including equipment qualification documentation, execution, and traceability within the system.
• Required: Strong hands-on Windchill knowledge, including engineering documentation and change management (ECR/ECN, BOM, routers).
• Working knowledge of equipment qualification/validation processes and documentation (IQ/OQ/PQ, requalification).
• Experience with cleaning validation principles, acceptance criteria, and supporting documentation.
• Experience with packaging validation, including seal process validation, package integrity testing, and distribution/aging studies.
• Experience with process changes, documentation, and cross-functional implementation.
• Hands-on proficiency with process transfers, Biological upgrades, equipment upgrade/change control, Gage R&R, control plans, and Vault DMR updates.

Education

Education & Experience Requirements

• Bachelor's degree in Mechanical, Biomedical, Manufacturing, Industrial, or a related engineering field.
• Minimum 3–5 years of manufacturing engineering experience in a regulated production setting.