Senior CQV Engineers � OSD & SDD

Pinnaql•Guaynabo, PR

About The Position

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.

Requirements

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.

Nice To Haves

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.

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.