CQV Technical Writer

• ​Develop, write, review, edit, and approve commissioning, qualification, and validation documentation, including IQ OQ PQ protocols, reports, and standard operating procedures (SOPs).

• Collaborate with cross-functional teams to gather technical information and ensure accurate representation in documentation.

• Ensure all documentation complies with industry standards, regulations, and company policies.

• Regularly review and update existing documentation to reflect changes in processes, equipment, or regulatory requirements.

• Identify and support process improvement efforts (root cause analysis/investigations/corrective actions/etc.).

• Communicate and collaborate with team members and project staff to plan, develop, and produce high-quality communication products in a fast-paced environment.

• Demonstrate excellent technical problem-solving skills to address complex validation challenges.

• Additional responsibilities as required.

• Bachelor's degree in a relevant scientific or engineering field.

• 3-5+years of experience supporting commissioning, qualification, and validation engineering projects and technical documentation.

• Proven ability to write clear, concise, and accurate technical documentation.

• Solid understanding of engineering principles, terminology, processes, and concepts.

• Strong understanding of industry regulations and standards.

• Excellent written and verbal communication skills.

• Ability to work independently and collaboratively in a remote team environment.

• Detail-oriented with a focus on accuracy and consistency.

• Strong organizational skills with the ability to multi-task and manage multiple documentation projects.

• Knowledge of risk-based validation principles.

• Familiarity with document management systems and electronic document control.

PSC Biotech