Senior Validation Engineer

3 days ago

Singapore NUSANTARA PRIME CONSULTING PTE LTD Full time

**Responsibilities**:

- Monitor day-to-day Validation activities in accordance with approved SOPs / Plan / Policies for a large scale, multi-product, GMP biotech contract manufacturing facility
- Participate in review and approval of Validation Protocols / Reports including site discrepancies and deviations investigation / closure
- Support / participate in validation activities during facility startup / shutdown / changeover and routine GMP operations
- Support / participate in Site Validation Maintenance Program and implementation of department training requirements
- Develop Validation Plans for a small to medium scale change implementation project and ensure the validation execution activity meets scheduled timelines
- Active coordination with internal and external validation resources to achieve department / project goals
- Liaise with system owners, quality unit and other relevant departments to ensure scope, execution and reporting of Site Validation Program meet expectations
- Review & assess Site Change Controls, implementation of Validation CAPAs and subsequent closure
- Participate in Customer / Agency Audits and Inspections as required
- Participate in on-job training program for staff and provide guidance to team members as required
- Any other task as assigned by Supervisor/Manager

**About You**:

- Diploma/Bachelor/Master/Doctoral Degree in Engineering/Science.
- Min. 5 to 7 years’ experience in the Validation / Quality unit in the Biopharmaceutical industry.
- Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, GAMP and ICHQ7)
- Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility
- Good interpersonal skills
- Effective Communicator (oral and written)
- Exhibit good quality decision making traits
- Meticulous and Systematic
- Analytical Mind
- Team player who can operate independently, with strong focus on safety, quality and timelines

**Notes**:

- Contract length: 12 months. Option to extend pending performance and business needs.
- Job Type: Contract
- All staff to observe MOH regulations and practices.

Contract length: 12 months

**Salary**: $4,000.00 - $5,500.00 per month

Schedule:

- Monday to Friday

COVID-19 considerations:
All staff to observe MOH regulations and practices.

**Experience**:

- Validation / Quality unit in the Biopharmaceutical industry.: 5 years (preferred)
- Pharma: 2 years (preferred)

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