Commissioning & Qualification Engineer

Smart Precise Solutions, Inc.; Humacao (PR); On-site; USD 40,000 - 55,000; Full time

Job summary

Smart Precise Solutions (SPS) is seeking a Commissioning & Qualification Engineer to prepare and execute validation documents for clients in regulated industries. The role is based in Humacao, PR with support at client sites in Ponce and Villalba.

Requirements include a Bachelor's in Engineering and 3–5+ years in commissioning/validation, strong cGMP knowledge, and fluency in English and Spanish. Travel between sites and after-hours work may be required.

Qualifications

• Bachelor's degree in Engineering or related field.
• 3–5+ years of commissioning, qualification and/or validation in a regulated industry.
• Solid knowledge of cGMP and industry standards.
• Excellent written and verbal communication in English and Spanish.
• Ability to write clear, concise engineering documentation.
• Proficient in MS Office 365 (Word, Excel, PowerPoint).
• Self-starter with strong teamwork, presentation and troubleshooting skills.
• Available to travel between Humacao, Ponce and Villalba, and to work beyond regular hours when needed.

Responsibilities

• Develop verification and qualification deliverables, including VMP, URS, FS, DS, IA, FAT, IQ/OQ/PQ protocols, SOPs, PM procedures and spare parts lists.
• Prepare, execute and review validation packages; analyze validation data for review and approval.
• Lead the resolution of deviations and non-conformances using technical knowledge.
• Write validation plans and risk assessments for specific projects and facilities.
• Track and manage applicable change control procedures.
• Review drawings and specifications; evaluate equipment quotations and vendor submittals.
• Organize and participate in client, contractor and vendor meetings; prepare minutes and close action items.
• Ensure systems and processes meet established specs and quality standards.
• Support SAP system management and other duties as assigned.

Skills

English-Spanish communication

Engineering documentation

Self-starter

Travel availability

Education

Bachelor's degree in Engineering

Tools

MS Office 365

SAP

Job description

Location:PR East & South Region
Salary: $40,000 - $55,000 per year
Job Type: Full-time

About the Role

Smart Precise Solutions (SPS) is looking for a Commissioning & Qualification (C&Q) Engineer to prepare and execute validation documents for our clients in regulated industries. The position is based in Humacao and also supports client sites in Ponce and Villalba. The right candidate understands cGMP, works confidently with clients, contractors, management and peers, and represents SPS professionally at client sites.

Key Responsibilities

• Develop verification and qualification deliverables, including the Validation Master Plan (VMP), User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Impact Assessments (IA), Factory Acceptance Tests (FAT), IQ/OQ/PQ protocols, SOPs, preventive maintenance procedures and spare parts lists.
• Prepare, execute and review validation packages; compile and analyze validation data for review and approval.
• Lead the resolution of deviations and non-conformances using technical knowledge.
• Write validation plans and risk assessments for specific projects and facilities.
• Track and manage the applicable change control procedures.
• Review engineering drawings and specifications; evaluate equipment quotations and vendor/contractor submittals.
• Organize and take part in technical, client, contractor and vendor meetings. Prepare meeting minutes and follow open items through to closure.
• Make sure systems and processes consistently meet established specifications and quality standards.
• Support SAP system management and other duties as assigned.

Qualifications

• Bachelor’s degree in Engineering or a related field.
• 3-5+ years of experience in commissioning, qualification and/or validation in a regulated industry (pharmaceutical, biotech or medical devices).
• Solid knowledge of cGMP and industry standards and requirements.
• Excellent written and verbal communication skills in English and Spanish.
• Ability to write clear, concise engineering documentation.
• Proficient in MS Office 365 (Word, Excel, PowerPoint).
• Self-starter with strong teamwork, presentation and troubleshooting skills.
• Available to travel between Humacao, Ponce and Villalba, and to work beyond regular hours when needed.

You’ll Stand Out If You Have

• Lean Manufacturing or Six Sigma certification
• SAP experience

Why SPS?

You’ll work on a variety of client projects across Puerto Rico, in a team that values quality, precision and great customer service.

SPS is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability or any other status protected by law.