Operations Documentation & CI Specialist (1-Year Contract)

Merck; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

Merck Singapore seeks an Operations Support Specialist to coordinate manufacturing activities for the Integrated Process Team (IPT). You will assist production supervisors with resource allocation, manage documentation, act as SAP Super-User, and lead CIP initiatives.

The role emphasizes compliance, batch record reviews, and continuous improvement within a fixed 1-year contract. The position requires engineering discipline, GMP knowledge, and strong collaboration across GTO/Process Engineering,

Qualifications

• Diploma or Degree in Engineering (Chemical, Mechanical or Electrical), Science or a related discipline
• 3-4 years (preferred) in an operations environment with experience in documentation preparation and control preferred
• Good knowledge in applicable regulations and GMP policies/guidelines (especially Cleaning/Housekeeping/Maintenance, Environmental Control, Process/Cleaning/ Equipment Validation, Change Control and Manufacturing Practices)
• Good stewardship awareness (including cGMP, regulatory inspection preparation, SHE)

Responsibilities

• Manufacturing Excellence: Prepare and issue necessary documents in a timely manner for manufacturing use.
• Support document revision (SOP, Forms, etc) when necessary to improve the system of documentation review, issuance and preparation.
• Completes manufacturing batch record review in accordance with cGMP requirements.
• Maintains proper filing and safe keeping of all relevant manufacturing documents and have them available when needed
• Batch Documentation Reviews: Complete post-manufacturing batch documentation reviews
• Provide straight-through document accuracy metrics and lead associated improvement initiatives
• SAP & MES User and Inventory Updates: Update BOMs for Pharm West products
• Test script execution for MES changes to MBR
• Ensure SAP inventory accuracy and support manufacturing-related stock adjustments and/or reversals
• Management of Manufacturing Aids and Consumables
• Create, release and close PO for products
• Others: Data collection and metric tracking to support Tier process
• Update APR and CPV for nominated Pharm West products
• Continuous Improvement (CI): Utilizes Lean Six Sigma Tools to support CI projects
• Initiate CI activities in area of responsibility - Batch document simplification, SOP & JA process review etc.
• Quality: Ensure that all assigned tasks related to manufacturing documentation support is in accordance with good manufacturing practices.
• Prepare or update SOPs and related documents to ensure compliance with regulatory standards.
• Actively engage in audits and support implementation of agreed follow-up actions.
• Safety, Health & Environment (SHE): Ensure that all assigned daily manufacturing activities are planned and carried out in accordance to SHE requirements.
• Participate in incidents investigations and audits
• Ensure regulatory permit requirements are met for IPT maintenance activities Promote SHE leadership behaviours
• ensure incident investigations and audits are fully supported with improvement actions implemented
• People Excellence: Self, Resilient and resourceful, Continuous learning mindset, Foster teamwork and cross collaboration, Strong work ethics, Effective communication skills

Skills

Analytical Problem Solving

Problem Solving

Business Agility

Change Management

Chemical Engineering

Continuous Development

Corporate Ethics

Documentation

Education

Engineering degree (Diploma/BE)

Job description

Merck Singapore seeks an Operations Support Specialist to coordinate manufacturing activities for the Integrated Process Team (IPT). You will assist production supervisors with resource allocation, manage documentation, act as SAP Super-User, and lead CIP initiatives.

The role emphasizes compliance, batch record reviews, and continuous improvement within a fixed 1-year contract. The position requires engineering discipline, GMP knowledge, and strong collaboration across GTO/Process Engineering,