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

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

2. Commissioning Activities

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

3. Qualification Execution (IQ/OQ/PQ)

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

4. Documentation & Compliance

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  Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal standards.
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  Maintain document lifecycle management within electronic systems.
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  Support data integrity and ALCOA+ principles throughout qualification activities.
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  Prepare and support validation summary reports.

5. Risk Management & Change Control

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  Lead and document risk assessments related to system qualification.
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  Evaluate and manage change controls impacting validated systems.
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  Assess deviations and implement corrective and preventive actions (CAPA).

6. Cross-Functional Collaboration

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

7. Process Characterization

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

Requirements

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  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.