Senior Validation Engineer

Responsibilities:

Process Validation:

1. Lead activities linked to the validation and the maintenance of the validated state of manufacturing processes, Sealing process, Crimping process or concerning the operation process, particularly Computerized System, for the current and new ranges of products. This includes:

• Participation in the issue and maintenance of the site's Validation Master Plan (VMP)

• Participation in the issue and follow-up of the periodical validation schedule

• Qualification of new equipment: write and/or review protocols and reports, lead tests

• Validation of new processes: write and/or review protocols and reports, lead tests

• Periodical review of the validated state of processes, planning of activities needed to maintain this state.

• Creating and updating validation work instructions.

• Establishing and updating the validation summary reports.

2. Participate in the qualification of equipment and the process validation, particularly sealing, crimping, assembly, thread treatments and printing processes, for the current and new products.

3. Review the mechanical tests methods validation.

4. Participate in the validation, the review, and the monitoring of suppliers/sub-contractors’ validation reports and certifications.

Miscellaneous:

1. Evaluate impact assessment of change process

2. Establish URS for new Computerized system. Participate in writing URS for other processes.

3. Participate in FAT/SAT activities for new equipment.

4. Establish risk analysis for computerized system and participate in FMEA activities for other processes.

5. Participate in activities related to Change Control

6. Manage samples retained for real-time and accelerated aging studies and keep the aging master file up to date.

7. Support during audits.

Qualification:

• Education: University graduate or engineer in one of the following fields: industrial, bio-medical, chemistry, mechanical
• Working experience: At least 5 years up in the medical device, pharmaceutical industry or related
  industries.
• Specific skill/knowledge:
  • Proficient in written and spoken English.
  • Experienced in Equipment Qualification and/or Process validation.
  • Knowledge of Computerized System Validation and GAMP®5 guidance.
  • Knowledge of Packaging processes.
  • Knowledge of standards ISO 11607 and ISO 13485.
  • Computer skills: word, excel, and power point (knowledge of Minitab would be a plus)
  • Project management skills.
• General knowledge:
  • Good team player and coordinator, able to work efficiently with deadlines.
  • Diligent, meticulous, attention to the details
  • Highly responsible and dependable
  • Willingness and ability to learn fast.