Sr. Engineer

Job Description

We are seeking a highly motivated Senior Engineer with strong experience in Assembly and Packaging Processes to support commissioning, qualification, and characterization activities within a regulated manufacturing environment.

Key Responsibilities

1. Commissioning & Qualification (C&Q) Strategy and Planning

• Develop and implement overall C&Q strategies aligned with project objectives and regulatory requirements.
• Define system boundaries and identify direct and indirect impact systems.
• Lead risk assessments using methodologies such as ISPE Baseline and ASTM E2500.
• Develop C&Q plans, schedules, and resource forecasts.

2. Commissioning Activities

• Lead and/or execute commissioning activities including FAT, SAT, and field commissioning.
• Ensure systems are installed and operating according to design specifications.
• Coordinate startup activities with vendors and contractors.
• Review and approve commissioning documentation and test results.

3. Qualification Execution (IQ/OQ/PQ)

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

4. Documentation & Compliance

• Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal standards.
• Maintain document lifecycle management 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 deviations and implement corrective and preventive actions (CAPA).

6. Cross-Functional Collaboration

• Partner 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 communications.

7. Process Characterization

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

Qualifications

Requirements

• Doctorate degree, or Master’s degree with 2+ years of experience, or
  Bachelor’s degree in Engineering with 4+ years of experience.
• Experience in GMP-regulated manufacturing environments.
• Strong understanding of FDA, EMA, ISPE, and ASTM guidelines.
• Experience with validation lifecycle documentation and risk-based qualification approaches.
• Excellent technical writing, communication, and collaboration skills.

Additional Information

All your information will be kept confidential according to EEO guidelines.