JOB DETAILS

JOB DETAIL

- Lead validation and qualification activities for manufacturing processes (e.g., sealing, crimping, assembly, printing), ensuring validated state is maintained across products and equipment.
- Develop, review, and manage validation documentation including VMP, protocols, reports, and work instructions.
- Conduct periodic reviews of process validation status and plan required activities accordingly.
- Support supplier/subcontractor validation oversight and mechanical testing validation.
- Manage change impact assessments, risk analyses (FMEA), URS creation for computerized systems, and participate in FAT/SAT for new equipment.
- Manage aging study samples and maintain relevant records.
- Provide support during internal and external audits.

REQUIRED WORK EXPERIENCE

- Bachelor’s degree in Industrial, Biomedical, Chemical, or Mechanical Engineering (or related fields).
- Minimum 5 years of experience in medical device or pharmaceutical manufacturing.
- Strong experience in process validation and equipment qualification; knowledge of CSV and GAMP®5.
- Understanding of packaging validation, ISO 11607 & ISO 13485 standards.
- Strong English proficiency and computer skills (Word, Excel, PowerPoint; Minitab is a plus).
- Excellent project coordination, detail orientation, responsibility, and ability to learn quickly.