Sr Engineer - Juncos, PR - 35630

Integrated Services for Productivity & Validation, Inc; Juncos (PR); On-site; USD 90,000 - 140,000; Full time

Job summary

Integrated Services For Productivity & Validation, Inc in Juncos, Puerto Rico seeks a senior engineer to develop and execute commissioning and qualification strategies aligned with GMP/FDA/EMA standards. You will lead risk assessments, define system boundaries, and manage IQ/OQ/PQ execution and documentation.

You will coordinate with Engineering, QA, Manufacturing, and Supply Chain, mentor junior engineers, and ensure compliant validation summaries and CAPA actions.

Qualifications

• Doctorate or Masters + 2 years of engineering experience, or Bachelor + 4 years of engineering experience.
• Experience with GMP, FDA, EMA and industry standards preferred.
• Ability to lead and mentor junior engineers and cross-functional teams.

Responsibilities

• Develop and implement the C&Q strategy aligned with regulatory requirements.
• Define system boundaries and impact assessment for qualification.
• Lead risk assessments (ISPE Baseline, ASTM E2500).
• Develop C&Q plans, schedules, and resource forecasting.
• Oversee commissioning activities including FAT, SAT, and field commissioning.
• Ensure systems operate per design specifications and coordinate with vendors.
• Review and approve IQ/OQ/PQ protocols and ensure traceability from URS to testing.
• Prepare and support validation summary reports and CAPA processes.
• Collaborate with Engineering, Validation, QA, Manufacturing, and Supply Chain.
• Document lifecycle management and data integrity per ALCOA+.
• Support project meetings and stakeholder communication.
• Characterization protocols and reports development and execution.

Skills

C&Q strategy

Risk assessment

IQ/OQ/PQ

GxP compliance

CAPA management

Documentation

Cross-functional teamwork

Mentorship

Education

Doctorate in Engineering

Master's in Engineering

Bachelor's in Engineering

Tools

Validation protocols

Document control software

LIMS/ELN systems

Job description

Integrated Services For Productivity & Validation, Inc | Contract

Juncos, Puerto Rico

Job Description

• Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements.
• Define system boundaries and identify direct/indirect impact systems.
• Lead risk assessments (e.g., ISPE Baseline, ASTM E2500) to determine qualification scope.
• Develop C&Q plans, schedules, and resource forecasting.
• Oversee and/or execute commissioning activities including FAT, SAT, and field commissioning.
• Ensure systems are installed and operate per design specifications.
• Coordinate with vendors and contractors during startup activities.
• Review and approve commissioning documentation and test results.

3. Qualification Execution (IQ/OQ/PQ)

• Author, review, and approve qualification protocols (IQ, OQ, PQ).
• Ensure traceability from User Requirements Specifications (URS) through testing.
• Execute or oversee protocol execution and ensure proper documentation of results.

4. Documentation & Compliance

• Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal Amgen standards.
• Maintain document lifecycle within electronic systems.
• Support data integrity and ALCOA+ principles throughout qualification activities.
• Prepare and support validation summary reports.
• Lead and document risk assessments related to system qualification.
• Evaluate and manage change controls impacting validated systems.
• Assess impact of deviations and implement corrective and preventive actions (CAPA).

6. Cross-functional Coordination

• Collaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain teams.
• Interface with system owners and technical authorities.
• Provide technical guidance and mentorship to junior engineers and project team members.
• Support project meetings, status reporting, and stakeholder communication.

7. Characterization Process

• Develop the characterization protocols.
• Execute the characterization activities.
• Develop and review the characterization reports

What will be the interview process?

30 minutes

Certifications Required

None

Requirements

• Doctorate OR -Masters + 2 years of Engineering experience OR
• Bachelors in Engineering + 4 years of Engineering experience.