C&Q Specialist | Pharmaceutical | Manatí, PR | On-Site

Job Description

Job Description

LOCATION: Manatí, Puerto Rico

Job Description

We are seeking a Commissioning & Qualification (C&Q) Specialist to support pharmaceutical manufacturing facilities located in the North Area of Puerto Rico (Manatí). The specialist will be responsible for supporting commissioning, qualification, validation, CSV, startup, and operational readiness activities for pharmaceutical equipment, utilities, facilities, computerized systems, and manufacturing areas while ensuring compliance with regulatory requirements and company standards.

The ideal candidate will have strong hands-on C&Q experience in pharmaceutical manufacturing environments, particularly in sterile manufacturing and packaging areas, including experience with autoclaves, clean utilities, HVAC systems, and Building Automation Systems (BAS). Experience with construction turnover, startup, operational readiness, electronic validation systems, and technical documentation is highly preferred.

This is a contract-based opportunity for an independent professional willing to work at the client site.

Main Responsibilities

• Develop and execute Commissioning, IQ/OQ/PQ, and qualification protocols for pharmaceutical equipment, utilities, facilities, and manufacturing systems.

• Support commissioning of clean utilities, HVAC, BAS, autoclaves, and other pharmaceutical systems.

• Support construction turnover, startup, qualification readiness, and operational readiness activities.

• Develop and execute electronic protocols and test scripts using electronic validation systems such as ALM or similar platforms.

• Support CSV activities, including requirements, risk assessments, testing, traceability, deviations, and validation documentation.

• Ensure C&Q and validation activities comply with cGMP, FDA requirements, company procedures, and quality standards.

• Support Change Controls, deviations, CAPA, investigations, and discrepancy resolution throughout project execution.

• Prepare and maintain protocols, reports, test documentation, SOPs, and qualification packages with complete traceability.

• Support system modifications, upgrades, requalification, decommissioning, and troubleshooting activities.

• Collaborate with Quality, Validation, Engineering, Automation, Manufacturing, Facilities, Utilities, Construction, CSV, and vendors to support successful project execution.

General Requirements

• Fluent in Spanish and English (spoken and written).

• Proficiency in Microsoft Office 365, including Teams, SharePoint, Outlook, Excel, Word, and PowerPoint.

• Strong technical writing and documentation skills in English.

• Strong understanding of cGMP regulations and pharmaceutical manufacturing requirements.

• Strong understanding of electronic documentation and protocol execution.

• Experience working with electronic validation systems, test execution, or lifecycle management platforms.

• Experience with ALM or similar electronic validation/lifecycle management systems is preferred.

• Excellent attention to detail and quality mindset.

• Effective communication skills and ability to interact with cross-functional teams.

• Strong analytical and problem-solving capabilities.

• Ability to manage multiple priorities and work in fast-paced pharmaceutical environments.

Education Requirements

• Bachelor’s Degree in Engineering, Life Sciences, Computer Science, Information Technology, or another related field.

Experience Requirements

• Minimum of 5 years of experience in Facilities/Utilities Commissioning, C&Q, Validation, Engineering Support, or related pharmaceutical projects.

• Experience working in pharmaceutical product manufacturing environments, preferably supporting sterile manufacturing and packaging areas.

• Hands-on experience with Commissioning & Qualification of pharmaceutical equipment and systems, including autoclaves, clean utilities, HVAC, and BAS (Building Automation Systems) such as Honeywell or similar platforms.

• Strong knowledge of cGMP regulations and experience working in FDA-regulated environments.

• Experience supporting construction turnover, qualification readiness, startup, and operational readiness activities for pharmaceutical facilities and systems.

• Hands-on experience developing, reviewing, and/or executing IQ/OQ/PQ and commissioning protocols.

• Experience with electronic protocols, electronic test execution, and electronic validation systems such as ALM or similar platforms is highly preferred.

• Experience with Computerized System Validation (CSV) activities is preferred.

• Experience supporting investigations, deviations, CAPA, and change control processes.

• Experience supporting cross-functional project execution and implementation activities.

• Experience with automation, control systems, manufacturing systems, or computerized equipment is a plus.

Physical Requirements

• Ability to sit for extended periods.

• Light physical activity may be required occasionally.

• Must be able to visit field locations as needed.

• Must be able to wear personal protective equipment (PPE) when required.

• Ability to work in a variety of industrial and pharmaceutical manufacturing environments.

• Ability to work on-site in Manatí, Puerto Rico.