Senior CQV Engineers � OSD & SDD

Pinnaql, Inc.; Puerto Rico; On-site; USD 120,000 - 160,000; Full time

Job summary

Validation & Engineering Group in the pharmaceutical sector seeks a Senior CQV Engineer with 10+ years of CQV experience focusing on Oral Solid Dosage (OSD) and Spray-Dried Dispersion (SDD) systems. The role covers commissioning, qualification, startup, and documentation to ensure regulatory compliance.

The successful candidate will lead protocol development, supervise startup activities, and troubleshoot processes while coordinating with manufacturing, quality, and validation teams to ensure

Qualifications

• CQV knowledge in pharmaceutical manufacturing and equipment validation.
• Experience leading commissioning, qualification, and verification activities.
• Ability to develop and execute equipment qualification protocols.

Responsibilities

• Lead commissioning, qualification, and verification activities for OSD and SDD systems.
• Develop and execute protocols for equipment qualification and validation.
• Conduct equipment startup and troubleshooting as needed.
• Generate and maintain regulatory-compliant technical documentation.
• Collaborate with cross-functional teams to ensure project success.
• Provide technical expertise and support to ensure cGMP compliance.

Skills

CQV expertise

Project management

Communication

Problem solving

Education

Bachelor's degree in Engineering

Tools

Tablet presses

Coaters

Dispensing systems

Spray dryers

Qualification protocols

Job description

Current job opportunities are posted here as they become available.

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:

Job Summary

We are seeking a Senior CQV Engineer with a minimum of 10+ years of relevant CQV experience in pharmaceutical manufacturing. The ideal candidate will have strong expertise in Oral Solid Dosage (OSD) manufacturing equipment, including tablet presses, coaters, dispensing systems, and associated manufacturing equipment. Additionally, experience with Spray-Dried Dispersion (SDD) systems, spray dryers, and related process equipment is required. Candidates should have hands-on experience with commissioning, qualification, verification, equipment startup, and technical documentation.

Qualifications

• Bachelor's degree in Engineering or related field.
• Minimum of 10 years of experience in CQV in the pharmaceutical industry.
• Proven expertise in OSD and SDD technologies.
• Strong knowledge of tablet presses, coaters, dispensing systems, and spray dryers.
• Experience with equipment startup, commissioning, and qualification processes.
• Ability to provide technical documentation and support across various equipment packages.
• Excellent communication and problem-solving skills.

Responsibilities

• Lead commissioning, qualification, and verification activities for OSD and SDD systems.
• Develop and execute protocols for equipment qualification and validation.
• Conduct equipment startup and troubleshooting as needed.
• Generate and maintain technical documentation following regulatory requirements.
• Collaborate with cross-functional teams to ensure successful project execution.
• Provide technical expertise and support to ensure compliance with industry standards.

Preferred Qualifications

• Master's degree in Engineering or related field.
• Professional certifications related to CQV in pharmaceutical manufacturing.
• Experience with regulatory inspections and audits.
• Familiarity with current Good Manufacturing Practices (cGMP).
• Ability to mentor junior engineers and team members.

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.