Senior CQV Engineer: OSD & SDD Validation Leader

Pinnaql, Inc.; Carolina (PR); On-site; USD 120,000 - 180,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a Senior CQV Engineer with 10+ years in pharmaceutical CQV to lead commissioning, qualification, and verification for OSD and SDD systems.

The candidate should have hands-on experience with tablet presses, coaters, dispensing systems, and spray dryers, and be proficient in creating regulatory documentation. The role requires collaboration across functions, development of qualification protocols, and active participation in equipment startup to

Qualifications

• Bachelor's degree in Engineering or related field.
• Minimum of 10 years of CQV experience 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.

Skills

CQV expertise

Regulatory documentation

Commissioning

Qualification

Cross-functional collaboration

Technical leadership

Education

Bachelor's degree in Engineering

Master's degree in Engineering (preferred)

Tools

OSD equipment knowledge

SDD systems

Job description

Validation & Engineering Group, Inc. is seeking a Senior CQV Engineer with 10+ years in pharmaceutical CQV to lead commissioning, qualification, and verification for OSD and SDD systems.

The candidate should have hands-on experience with tablet presses, coaters, dispensing systems, and spray dryers, and be proficient in creating regulatory documentation. The role requires collaboration across functions, development of qualification protocols, and active participation in equipment startup to