Biotechnologist III (Central Services)

ONE STOP ENGINEERING PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

ONE STOP ENGINEERING PTE. LTD. is seeking a qualified candidate for a GMP-biologics manufacturing role in a production facility. The position involves supporting manufacturing operations, calibration tasks with engineers, rework and quality testing of parts and final materials.

The ideal candidate will have a bachelor’s degree, 1–5 years of relevant experience, and solid knowledge of GMP, lab procedures, and documentation. Strong writing and teamwork are essential.

Qualifications

• Bachelor’s degree or equivalent required.
• 1-5 years relevant experience with good writing skills.
• Knowledge of media/buffer preparation, cell culture or purification of biological drugs.
• Working knowledge of safety, quality systems and GMP.
• Ability to handle multiple tasks and work under pressure.

Responsibilities

• Transfers methods into Production instructions for campaigns.
• Schedules tasks and drafts moderate scope documents; manages reviews and approvals.
• Collaborates with management to determine action within procedures.
• Analyzes data to develop solutions for moderate problems.
• Supports production initiatives and ensures compliant procedures.
• Coordinates activities across sub-groups and communicates with supervisors.

Skills

Good writing

Documentation

Team player

Communication

Problem solving

Computer literacy

GxP knowledge

Education

Bachelor’s Degree or equivalent

Tools

LIMS

SAP

Automated control systems

Job description

Job Description

Purpose Statement

• Performs functions associated with current Good Manufacturing Practices manufacturing operations within the biologics production facility, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components and final materials.
• Uses sophisticated programs (such as LIMS, SAP, automated control systems, etc.) to collect and evaluate operating data, which can be used to conduct on-line adjustments to products, instruments or equipment.
• Determines and may assist in developing methods and procedures to control or modify the manufacturing process.

Major Responsibilities:

• Transfers methods into Production instructions to allow for successful performance of scheduled campaigns.
• Schedules work tasks, with general assistance, to support project and campaign timelines. Drafts moderate scope and complexity documents. Circulates documents to reviewers with general assistance, responds to comments and questions. Manages document review and approval to meet project timelines and provides status reports to management.
• Works with management and senior staff to determine appropriate course of action within defined procedures. Tracks ongoing problems and gathers information for analysis. Analyzes data to develop solutions to moderate-level problems.
• Applies knowledge, experience, and technical skills to understand ABC production objectives, to provide support to production initiatives, to execute procedures efficiently and compliantly, and use standard practices to ensure inter-group consistency.
• Works on problems of moderate complexity, where analysis of situations requires evaluation of several factors.
• Exercises judgment within defined procedures and policies to determine appropriate action. Discusses action with senior staff.
• Coordinates activities of sub-group and actively works with other sub-groups. Frequently interacts with subordinates and supervisor.

Qualifications

• Bachelor’s Degree or equivalent required.
• At least 1-5 years relevant experience with good writing skills.
• Working knowledge of media/buffer preparation, cell culture or purification of biological drugs is required.
• Computer proficiency. A working knowledge of safety, quality systems, and current Good Manufacturing Practices is required. Familiarity with tech transfer processes.
• Must be flexible to handle multiple tasks including ability to handle pressure in a professional manner. Effectively work in a team environment. Maintain a high level of energy and professionalism on the job. Build effective working relationships with customers, co-workers, cross-functioned groups, and management.
• Basic understanding of current Good Manufacturing Practices as applied to equipment and process steps in area of responsibility.