C&Q Document Preparation Support (Drug Product)

This position may support one or more areas including Drug Substance, Drug Product, Finished Drug Product & Packaging, or Facilities & Utilities.

Roles & Responsibilities

• Prepare and revise commissioning and qualification lifecycle documentation supporting Engineering projects and systems

• Author qualification protocols, reports, risk assessments, traceability matrices, test scripts, and related C&Q documentation

• Support document development activities using approved templates, standards, and CoE procedures

• Coordinate technical review cycles and incorporate comments and revisions into final documents

• Ensure documentation is accurate, complete, compliant, and inspection-ready

• Partner with Engineering, Validation, Quality, Manufacturing, Facilities, and Project teams to gather technical information

• Track assigned deliverables and support execution against project schedules and milestones

• Maintain document organization and version control within applicable quality systems

• Support audit and inspection readiness activities as required

• Contribute to continuous improvement initiatives focused on documentation quality, consistency, and efficiency

Area-Specific Experience Preferred

• Experience supporting commissioning and qualification activities for drug product manufacturing systems
• Familiarity with formulation, compounding, filling, lyophilization, and aseptic processing equipment
• Understanding of sterile manufacturing practices, contamination control strategies, and cleanroom operations preferred
• Experience preparing qualification documentation supporting aseptic processing systems and manufacturing operations
• Familiarity with process equipment qualification including mixers, filling lines, isolators, and autoclaves preferred
• Experience supporting startup or qualification activities for sterile manufacturing capital projects preferred

Preferred / Good to Have Qualifications & Skills

• Experience in GMP commissioning, qualification, validation, or technical operations

• Experience authoring C&Q lifecycle documentation including qualification protocols and reports

• Familiarity with risk-based qualification methodologies and lifecycle validation approaches

• Knowledge of GMP documentation practices and data integrity requirements

• Experience working in a fast-paced capital project or startup environment preferred

• Strong written and verbal communication skills

• Strong organizational skills and attention to detail

• Experience working in cross-functional project teams

Key Competencies

• Technical Writing and Documentation Excellence

• Attention to Detail and Quality Focus

• Cross-Functional Collaboration

• Planning and Execution

• Problem Solving and Analytical Thinking

• Continuous Improvement Mindset

• Communication and Stakeholder Partnership

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