Sr Validation Specialist

Validation & Engineering Group, Inc.; Juncos (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

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.

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

Commissioning

Qualification

Packaging

Regulatory compliance

Documentation

Communication

Problem solving

Ownership & initiative

Job description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Sr Validation Specialist.

Job Summary

We are seeking a mid-level Validation professional to support Packaging operations within Process Development (PD). This role will focus on executing C&Q activities for packaging equipment and systems, ensuring compliance with regulatory standards while supporting project timelines. The ideal candidate is proactive, adaptable, and demonstrates strong ownership and initiative.

Key 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.

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.

Additional Requirements

• Availability to work 2nd and 3rd shifts as required to support project timelines.

Preferred Skills

• Familiarity with cGMP regulations and validation lifecycle.
• Experience working in Process Development (PD) environments is a plus.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.