Senior Validation Engineer
7 months ago
**Responsibilities**:
- Support equipment qualification, system qualification, and cleaning validation.
- Develop, review and/or approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion.
- Review Turnover / Vendor Packages as part of the project deliverables to support qualification activities.
- Manage qualification execution and lead validation deviation investigations encountered in qualification.
- Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification activities.
- Able to manage cross function stakeholders, and to lead / facilitate meeting and discussion relevant to project qualification/ validation activities.
- Participate in site Validation Maintenance Program
- Support Change Implementation on site
- Any other tasks assigned by Manager.
**About You**:
- Engineering/Science Degree or higher from recognised institution
- At least 5 years of experience in Equipment Qualification in the pharmaceutical/biotech industry. Experience in Critical Utilities, Cleaning validation and temperature mapping is preferred.
- Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility
- Good Knowledge of Upstream, Downstream and Support Services equipment within the Pharma Biotech Industry.
- Good oral and written communication skills.
- Meticulous and Systematic
- Team player, with strong focus on safety, quality and timeline
- GMP/cGMP knowledge a plus
- PMP certification a plus
- Self-motivated and capable of working in diverse team situations with company clients and maintaining a positive attitude towards project challenges.
- Bilingual in English (Written and Spoken) as well as in Indonesian (Written and Spoken).
**Job Type**: Contract
Contract length: 12 months
**Salary**: From Rp12,000,000 per month
Ability to commute/relocate:
- Jakarta: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- Validation: 5 years (preferred)
- Equipment Qualification: 5 years (preferred)
- Validation deviation investigations: 5 years (preferred)
License/Certification:
- PMP Certification (preferred)
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