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Jobs or company...
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Senior Validation Engineer

$ 5,000 - $ 10,000 / month
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Job Description:

The role involves owning, executing, and improving the validation lifecycle from planning to retirement for manufacturing processes and equipment. This includes, but is not limited to, oversight of Equipment, Facility, and Utility Qualification, Cleaning Validation, and Shipping Validation in partnership with Distribution. Additionally, the Senior Validation Engineer administers the Periodic Review and Revalidation Program. The Senior Validation Engineer is accountable for ensuring compliance with PQS and HA requirements and represents the Validation program during HA inspections. The role will reports to the Senior Validation Engineering Manager

Responsibilities:

· Support the day-to-day operation of approved Validation SOPs / Plan / Policies for a multi-platform, multi-product, GMP biotech contract manufacturing facility.

· Develop, review and approval of Validation SOPs, templates, guidelines, Validation Protocols and Reports including supporting site discrepancies and deviations investigation / closure in line with corporate policies and standards.

· Provide guidance and direction on all validation activities at the Singapore site.

· Ensure that all validation activities with respect to cleaning, sterilization and facilities/equipment stated in validation plan/ protocol are carried out in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion.

· Participate actively in investigations or troubleshooting discrepancies/ deviation encountered during commissioning and qualification.

· Generate training materials, conduct workshops on validation activities, and serve as a technical subject matter expert (SME).

· Provide on-call support for urgent validation requests, participate in site Validation Maintenance Program, and ensure compliance with Safety, Health & Environmental (SHE) requirements.

· Project and Change Management: Lead validation activities for new product introductions, support change implementation, and participate in external regulatory inspections as an SME.

· Continuous Improvement and Security: Promote validation awareness, embody Lean Production System (LPS) principles, and observe site security measures.

Job Type: Full-time

Pay: $5,000.00 - $10,000.00 per month

Benefits:

  • Cell phone reimbursement
  • Dental insurance
  • Flexible schedule
  • Free parking
  • Health insurance
  • Parental leave
  • Professional development
  • Vision insurance

Schedule:

  • Monday to Friday

Supplemental Pay:

  • Performance bonus

Experience:

  • Validation: 5 years (Required)

Location:

  • Singapore 637394 (Preferred)

Work Location: In person