Full Time Technical Writer Jobs, in Confidential Careers - Maukerja

We are seeking a Technical Writer to join our pharmaceutical startup in Singapore as we establish and commission our manufacturing operations and progress through IOPQ. The successful candidate will play a critical role in building a robust, controlled and inspection-ready documentation system covering GxP documentation, SOPs, URS, qualification/validation documents, work instructions, protocols, reports and other technical documentation.

This is a hands-on role suited to someone who can work closely with QA, Engineering, Manufacturing, Validation, QC and external vendors/consultants, translate technical requirements into clear controlled documents, and ensure documentation is complete, consistent and suitable for a regulated pharmaceutical environment.

Key Responsibilities

1. Pharmaceutical Documentation

• Develop, draft, review and maintain controlled pharmaceutical documentation.
• Prepare and coordinate SOPs, work instructions, forms, templates, protocols and reports.
• Support development of documentation required for facility, equipment, utilities and manufacturing systems.
• Ensure documents are clear, technically accurate, traceable and aligned with approved processes.
• Maintain consistency in terminology, formatting, document numbering and revision control.
• Incorporate comments and feedback from SMEs while maintaining document integrity and version control.

2. URS & Engineering/Qualification Documentation

Support preparation, review and maintenance of:

• User Requirement Specifications (URS)
• Functional/design specifications where required
• Equipment and system specifications
• Risk assessments
• Design review documentation
• FAT/SAT documentation
• IQ/OQ/PQ/IOPQ protocols and reports
• Commissioning and qualification documentation
• Traceability matrices
• Deviation and punch-list documentation
• Change-control documentation
• Validation/qualification summary reports

Work closely with Engineering, Validation and QA SMEs to convert technical input into structured, auditable documentation.

3. SOP Development

• Develop SOPs covering manufacturing, equipment operation, cleaning, maintenance, calibration, documentation practices and other operational processes.
• Interview SMEs and process owners to understand actual workflows.
• Translate technical processes into practical, unambiguous and user-friendly instructions.
• Ensure SOPs appropriately address GMP/GxP expectations, roles and responsibilities, safety, documentation requirements and acceptance criteria.
• Coordinate review, approval, issuance and periodic revision of SOPs.

4. IOPQ / Commissioning Support

As the company progresses through commissioning and qualification:

• Prepare and format qualification protocols and reports.
• Compile technical evidence and supporting documentation.
• Maintain document trackers and status reports.
• Ensure protocol/report content is complete and internally consistent.
• Support closure of documentation-related observations, comments and discrepancies.
• Coordinate inputs from Engineering, Validation, QA, Manufacturing and vendors.
• Maintain traceability between requirements, qualification activities, results and conclusions.

5. Quality & Compliance

• Work within the company's Quality Management System (QMS) and document-control processes.
• Ensure documentation follows applicable GMP/GxP requirements and Good Documentation Practices (GDP).
• Support inspection readiness through accurate, complete and traceable documentation.
• Identify gaps, inconsistencies or missing information and proactively follow up with relevant stakeholders.
• Support document review and remediation activities arising from internal audits, regulatory inspections or quality reviews.

6. Cross-Functional Collaboration

• Work directly with QA, QC, Manufacturing, Engineering, Validation, Automation/IT, Supply Chain and external consultants/vendors.
• Facilitate documentation workshops and SME interviews.
• Clarify technical information and resolve documentation gaps.
• Establish practical documentation standards that can scale as the startup grows.

Required Qualifications & Experience

• Degree or diploma in Technical Writing, Life Sciences, Pharmaceutical Sciences, Engineering, Chemistry, Biotechnology or a related discipline.
• 3–7+ years of technical writing/documentation experience, preferably within pharmaceutical, biotechnology, medical device, chemical manufacturing or another regulated GxP environment.
• Demonstrated experience preparing SOPs, URS, protocols, reports and technical/qualification documentation.
• Understanding of GMP/GxP and Good Documentation Practices.
• Experience working with technical SMEs and converting complex technical information into clear documentation.
• Excellent attention to detail and document-control discipline.
• Ability to manage multiple documents and deadlines in a fast-moving startup environment.

Highly Desirable

• Experience in pharmaceutical manufacturing.
• Experience with IQ/OQ/PQ, IOPQ, FAT/SAT and equipment qualification.
• Familiarity with pharmaceutical facilities, HVAC, purified water, compressed air, process equipment and manufacturing utilities.
• Experience with risk assessments, change controls, deviations/CAPA and validation documentation.
• Familiarity with ALCOA+ principles and data integrity expectations.
• Experience working with equipment suppliers, engineering firms or validation consultants.