Technical Writer (6 months contract)
Consortium for Clinical Research and Innovation Singapore, Pioneer, OH, United States
At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.
We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.
Position Overview The Technical Writer (CQV) is responsible for the development, review, and management of commissioning, qualification, and validation (CQV) lifecycle documentation within a regulated pharmaceutical or biotechnology environment. This role ensures that all documentation is aligned with GMP requirements and industry standards, supporting equipment, utilities, and system validation activities. The Technical Writer works closely with cross‑functional teams, including Engineering, QA, and Automation, to gather technical inputs, maintain document integrity, and support project timelines. This is a hands‑on role requiring strong attention to detail, compliance awareness, and the ability to manage documentation across multiple project phases.
Key Responsibilities
Develop and review CQV lifecycle documents, including URS, DQ summaries (as applicable), IQ, OQ, and PQ protocols and reports
Author validation protocols and reports in accordance with site procedures and regulatory expectations
Ensure proper document formatting, version control, and traceability throughout the document lifecycle
Coordinate with CQV engineers, QA, and project stakeholders to gather and verify technical inputs
Support document revisions, approvals, and close‑out activities to meet project timelines
Ensure documentation aligns with GMP (EU/FDA), Annex 15, ASTM E2500, and site‑specific quality systems
Maintain audit‑ready documentation by ensuring completeness, accuracy, and compliance
Track documentation status and support timely delivery of validation deliverables
Assist in risk assessments, traceability matrices (RTM), and change control documentation
Collaborate with cross‑functional teams including Engineering, QA, Automation, and external vendors
Required Qualifications
Degree or Diploma in Engineering, Life Sciences, or a related discipline
3–5 years of experience in CQV documentation within the pharmaceutical or biotechnology industry
Proven experience in authoring IQ/OQ/PQ protocols and reports
Strong understanding of GMP requirements and validation lifecycle principles
Experience with qualification of process equipment, utilities, or cleanroom systems
Familiarity with URS, RTM, and risk assessment methodologies
Exposure to electronic documentation systems (e.g., Veeva, Kneat, TrackWise) is an advantage
Generous Leave Policy.
Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.
How to apply Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!
Please submit your resume, outlining your qualifications and experience relevant to the role, here.
#J-18808-Ljbffr
We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.
Position Overview The Technical Writer (CQV) is responsible for the development, review, and management of commissioning, qualification, and validation (CQV) lifecycle documentation within a regulated pharmaceutical or biotechnology environment. This role ensures that all documentation is aligned with GMP requirements and industry standards, supporting equipment, utilities, and system validation activities. The Technical Writer works closely with cross‑functional teams, including Engineering, QA, and Automation, to gather technical inputs, maintain document integrity, and support project timelines. This is a hands‑on role requiring strong attention to detail, compliance awareness, and the ability to manage documentation across multiple project phases.
Key Responsibilities
Develop and review CQV lifecycle documents, including URS, DQ summaries (as applicable), IQ, OQ, and PQ protocols and reports
Author validation protocols and reports in accordance with site procedures and regulatory expectations
Ensure proper document formatting, version control, and traceability throughout the document lifecycle
Coordinate with CQV engineers, QA, and project stakeholders to gather and verify technical inputs
Support document revisions, approvals, and close‑out activities to meet project timelines
Ensure documentation aligns with GMP (EU/FDA), Annex 15, ASTM E2500, and site‑specific quality systems
Maintain audit‑ready documentation by ensuring completeness, accuracy, and compliance
Track documentation status and support timely delivery of validation deliverables
Assist in risk assessments, traceability matrices (RTM), and change control documentation
Collaborate with cross‑functional teams including Engineering, QA, Automation, and external vendors
Required Qualifications
Degree or Diploma in Engineering, Life Sciences, or a related discipline
3–5 years of experience in CQV documentation within the pharmaceutical or biotechnology industry
Proven experience in authoring IQ/OQ/PQ protocols and reports
Strong understanding of GMP requirements and validation lifecycle principles
Experience with qualification of process equipment, utilities, or cleanroom systems
Familiarity with URS, RTM, and risk assessment methodologies
Exposure to electronic documentation systems (e.g., Veeva, Kneat, TrackWise) is an advantage
Generous Leave Policy.
Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.
How to apply Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!
Please submit your resume, outlining your qualifications and experience relevant to the role, here.
#J-18808-Ljbffr