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Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI. 

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Main Purpose of the Role:

The main purpose of the engineering technical writer is to effectively communicate complex engineering concepts, technical information, and processes to various audiences through the creation of clear, accurate, and user-friendly documentation. This documentation serves to educate, inform, and guide users, engineers, and other stakeholders in understanding and utilizing engineering products, systems, and processes. By distilling intricate technical details into comprehensible written materials, the technical writer will play a vital role in bridging the gap between complex engineering information and its practical application.

Main responsibilities:

  • Collaborate with engineering, validation, manufacturing, and quality assurance teams to gather technical information and ensure accuracy and compliance in documentation for pharmaceutical equipment, processes, and related activities.
  • Plan, develop, and maintain a variety of technical documents, including equipment specifications ( URS ), engineering drawings, installation and maintenance manuals, management of change (MOC) for new and existing equipment and standard operating procedures (SOPs).
  • Ensure that all documentation adheres to regulatory and industry standards, including HPRA , FDA, EMA, and other relevant guidelines, and support inspections and audits as needed.
  • Work closely with cross-functional teams to review, edit, and improve technical documentation based on feedback, changes in processes, or regulatory updates, ensuring alignment with current engineering and manufacturing practices.
  • Research and analyse complex engineering and technical information, translating it into user-friendly and comprehensive documentation for various stakeholders, including operators, engineering staff, and regulatory agencies.
  • Revise, update, and maintain existing documentation to reflect changes in equipment, processes, standards, or regulations, and ensure that documentation is readily accessible through the quality management system. ( Master Control. )

Essential: 

  • Proven experience as a technical writer in the pharmaceutical or engineering industry, with a strong understanding of engineering principles, pharmaceutical manufacturing processes, and regulatory requirements.
  • Bachelor's degree in engineering, mechanical engineering, chemical engineering, technical writing, or a related field.

Knowledge:

  • Excellent writing, editing, and proofreading skills, with a keen attention to detail and a commitment to producing high-quality and compliant documentation for pharmaceutical equipment and processes.
  • Familiarity with engineering documentation and regulatory requirements, including experience with technical drawing interpretation.
  • Strong interpersonal and communication skills, with the ability to work effectively with cross-functional teams, engineering professionals, and regulatory agencies.

Regulatory/Industry Responsibilities: 

  • The technical writer plays a critical role in ensuring the accuracy, clarity, and compliance of various types of documentation, thereby contributing to the successful development, approval, and safe use of pharmaceutical products. Their work helps to uphold regulatory standards.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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Confirmed 6 hours ago. Posted 30+ days ago.

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