Packaging Validation Specialist – cGMP & CQ Lead

Validation & Engineering Group, Inc.; Juncos (PR); In loco; USD 80.000 - 110.000; Tempo pieno

Descrizione del lavoro

Validation & Engineering Group, Inc. is seeking a Sr Validation Specialist to support packaging operations within Process Development.

You will execute commissioning and qualification activities for packaging equipment, develop C&Q documentation, and collaborate with Engineering, Quality, and Manufacturing to ensure project success. The ideal candidate has mid-level experience in C&Q within pharma/biotech/medical device industries, strong ownership, and excellent communication skills.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Commissioning

Qualification

Packaging

Regulatory compliance

Documentation

Communication

Problem solving

Ownership & initiative

Descrizione del lavoro

Validation & Engineering Group, Inc. is seeking a Sr Validation Specialist to support packaging operations within Process Development.

You will execute commissioning and qualification activities for packaging equipment, develop C&Q documentation, and collaborate with Engineering, Quality, and Manufacturing to ensure project success. The ideal candidate has mid-level experience in C&Q within pharma/biotech/medical device industries, strong ownership, and excellent communication skills.