C&Q Engineer, Sr.

About Ultimate Solutions Corp.

Ultimate Solutions is a trusted provider of packaging industrial automation serialization and regulatory compliance for the life science industries. For over 20 years the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to global leaders in the pharmaceutical biotechnology medical device and logistics sectors.

Key Responsibilities

• Plan coordinate and execute commissioning and qualification (C&Q) activities for Packaging Equipment.
• Develop and review C&Q documentation including protocols test scripts reports and traceability matrices.
• Perform Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) testing.
• Ensure equipment and systems meet design specifications user requirements and applicable regulatory standards.
• Collaborate with project managers engineering validation automation quality and manufacturing teams to align on project timelines and deliverables.
• Troubleshoot and resolve issues identified during C&Q execution.
• Support change control deviation investigations and CAPA activities.
• Maintain compliance with GMP safety and environmental requirements throughout project execution.
• Ensure all C&Q documentation is complete accurate and audit-ready.

• Bachelors degree in Engineering Life Sciences or related field.
• 6 years of experience in commissioning qualification or validation within a GMP-regulated environment.
• Strong and proven knowledge of the complete equipment validation life cycle including URS FAT/SAT IQ OQ and PQ documentation and execution.
• Experience with Packaging Equipment is strictly required particularly Dividella Cartoner and ATS Assembly Systems.
• Deep understanding of GMP regulations ISPE Baseline Guides and ASTM E2500 principles.
• Ability to read and interpret P&IDs electrical schematics and system design documents.
• Experience with automation systems process equipment and utilities in pharmaceutical or biotechnology manufacturing.
• Excellent technical writing analytical and organizational skills.
• Strong communication and teamwork abilities.

• Ability to multi-task and work under pressure.
• Capable of understanding complex problems collaborating across disciplines and developing effective solutions.
• Ability to negotiate and integrate different viewpoints in highly complex situations.
• Proficiency in composing technical documents outlines and concise reports as well as communicating technical information effectively.

Ultimate Solutions USA LLC is an equal opportunity employer. The company prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race color religion sex national origin disability status protected veteran status or any other characteristic protected by law.