Senior CQV Engineers – OSD & SDD

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. (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 CQV Engineer - OSD & SDD

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.

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.