What are the responsibilities and job description for the Commissioning, Qualification, and Validation Tech Writer from Pharma position at Combined Computer Resources?
Job Details
We are seeking a highly skilled Contractor CQV (Commissioning, Qualification, and Validation) Tech
Writer to join our team. The ideal candidate will be responsible for creating comprehensive test plans for
PLC (Programmable Logic Controllers) and DeltaV DCS platforms, including OITs (Operator Interface
Terminals), HMIs (Human-Machine Interfaces), and SCADA (Supervisory Control and Data Acquisition)
systems. These tasks and deliverables are essential for ensuring that GMP facilities and batch process
control systems are properly documented, validated, and compliant with industry standards and
regulatory requirements.
Key Responsibilities:
Creating and Managing Change Controls: Developing and maintaining documentation for change
controls related for continuous improvement, corrective and preventive actions (CAPAs), and
other sustainment type projects.
Collaborating with Cross-Functional Teams: Working closely with engineering, validation, and
quality assurance teams to gather information and ensure that all documentation is accurate and
complete. Liaising with various departments to integrate data and ensure consistency in
documentation practices.
Develop detailed test plans and protocols for PLC and/or DeltaV platforms. Developing IOQ
(Installation/Operational Qualification) Protocols form design documents such as URS, DDS,
FDS/FRS and creating IOQ protocols or change controls. May include OITs, HMIs, and SCADA
systems.
Participate in commissioning and qualification activities as needed.
Participate in Automation System Design Risk Assessments
Overseeing the storage, categorization, and retrieval of both electronic and physical documents
to ensure easy access and traceability.
Reviewing, verifying, and validating documents for accuracy and completeness, making
corrections where necessary, following Good Documentation Practices.
Ensuring all documentation meets internal standards and regulatory compliance requirement.
Qualifications:
Bachelor's degree in Engineering, Computer Science, or a related field.
Proven experience in technical writing, preferably in the pharmaceutical or biotechnology
industry.
Solid understanding of PLC and DeltaV platforms, as well as OITs, HMIs, and iFIX SCADA systems.
Understands PLC ladder logic and basic troubleshooting skills.
Excellent written and verbal communication skills.
Experience working in cGMP and in electrically classified environments (Class 1 Div1 / Div2)
where Safety is paramount.
Attention to detail and ability to work independently.
Familiarity with industry standards and regulatory requirements.
