Sr Engineer
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Key details
- Location
- Juncos, PR, United States
- Work style
- Onsite
- Level
- Senior
- Job type
- Contract
- Experience
- 2–5 yrs
- Function
- Software engineering
- Focus area
- other
- Posted
- 1w ago
Skills
capachange controlgmprisk assessment
About the role
We are seeking Sr Engineer with experience in Medical Devices or Pharma industry.
Duties:
1. C&Q Strategy & Planning
- 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.
2. Commissioning Activities
- 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.
5. Risk Management & Change Control
- 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
Requirements
- Doctorate or Masters + 2 years of Engineering experience or
Bachelors in Engineering + 4 years of Engineering experience - Bilingual (Spanish/English)
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