Senior Validation Specialist - Packaging & PD

Pinnaql, Inc.; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. in the United States is seeking a Sr Validation Specialist to support packaging operations within Process Development (PD).

The role focuses on executing commissioning and qualification activities for packaging equipment and systems, ensuring compliance with cGMP and quality standards. Ideal candidates bring mid-level CQ experience, strong ownership, and the ability to collaborate with Engineering, Quality, Manufacturing, and PD to drive project success.

Qualifications

• Mid-level experience in Commissioning & Qualification within pharmaceutical, biotechnology, or medical device industries.
• Experience or exposure to packaging equipment and processes is preferred.
• Strong sense of ownership, accountability, and initiative.
• Ability to work independently and manage priorities in a dynamic environment.
• Strong communication and problem-solving skills.

Responsibilities

• Execute commissioning and qualification activities for packaging equipment and systems within PD environments.
• Support the development and execution of C&Q documentation, including protocols, test scripts, and reports.
• Collaborate with cross-functional teams such as Engineering, Quality, Manufacturing, and PD to ensure alignment and project success.
• Assist in troubleshooting and resolving issues related to packaging systems during qualification activities.
• Ensure compliance with cGMP and internal quality standards.
• Maintain accurate documentation and provide timely updates on project progress.
• Support continuous improvement initiatives within packaging and qualification processes.

Skills

Packaging experience

Documentation

Communication

Problem-solving

Ownership

Job description

Validation & Engineering Group, Inc. in the United States is seeking a Sr Validation Specialist to support packaging operations within Process Development (PD).

The role focuses on executing commissioning and qualification activities for packaging equipment and systems, ensuring compliance with cGMP and quality standards. Ideal candidates bring mid-level CQ experience, strong ownership, and the ability to collaborate with Engineering, Quality, Manufacturing, and PD to drive project success.