Biotechnology Validation Engineer Position
4 days ago
We are seeking an experienced Validation Engineer to join our team at PSC BIOTECH PTE. LTD.
About the RoleThis is a unique opportunity to work in a fast-paced biotechnology environment where you will be responsible for ensuring the validation of various equipment and systems.
Key Responsibilities:- Commissioning Support: Assist with the review of Process and Instrumentation Diagrams (P&IDs) during commissioning phase.
- Change Control Management: Generate Change control documents and System Impact Assessments using Kneat.
- Vendor Document Review: Verify vendor documents for completeness.
- SAT Support: Provide support for Systems Acceptance Testing (SAT).
- Document Generation: Create validation documents and protocols for equipment, including process equipment and utility systems, both paper-based or using e-validation systems like Kneat.
- IQ and OQ Execution: Execute Installation Qualification (IQ) and Operation Qualification (OQ), and provide review/support as needed.
- Change Control Implementation: Close out Change Control implementation tasks.
- Collaboration: Work independently with project managers, vendors, and contractors to achieve project goals.
- Quality Service: Provide Quality service adhering to Standard Operating Procedure (SOP) requirements.
- Project Support: Give necessary support for the timely completion of projects.
- On-Site Presence: Be present on-site to provide full-time support.
- Equipment Expertise: Demonstrate expertise in computerized systems, particularly Agilent LCMS and GCMS.
- Bachelor's Degree in a relevant field, such as Life Sciences, Electrical Engineering, or a related discipline.
- Strong Technical Skills: Proficiency in C# and experience with DCS, SCADA, and GMP.
- Excellent Analytical Skills: Ability to perform Root Cause Analysis and interpret data effectively.
- Communication Skills: Excellent communication and interpersonal skills to collaborate with cross-functional teams.
- Temperature Mapping and Cleanroom Qualification experience.
PSC BIOTECH PTE. LTD. is a leading biotechnology company dedicated to delivering innovative solutions. We offer a competitive salary and benefits package, including a base salary of $80,000 - $110,000 per annum, depending on experience, plus additional compensation and benefits.
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