DP Process Validation Technical Writer & Document Manager

DP Parenteral Process Validation Technical Writer and Document Workflow Manager (m/f/d) - Parenteral Drug Product aseptic process development / technical writing experience / regulatory documents / IT tool to manage text processing / English

Project:
For our customer a big pharmaceutical company in Basel we are looking for DP Parenteral Process Validation Technical Writer and Document Workflow Manager (m/f/d).

Background:
The department Pharmaceutical Development within Pharma Technical Development is responsible for the development of parenteral (biologics and synthetic molecules) drug product formulation and processes from Phase 1 up to commercial launch.

Process validation is documented assurance of consistent process performance and product quality that meets Health Authority regulations for our patients.

The Technical Writer and Document Workflow Manager is responsible for authoring and managing the review and approval of process validation and regulatory documents (IND and IMAs). Converts scientific data into clear, scientifically sound, well-structured scientific internal and regulatory documents intended for global health authorities and stakeholders, which are based on respective model documents. Understands purification process development and has an excellent knowledge of purification process validation.

The perfect candidate:
has a Bachelor's degree or Master's degree in a scientific discipline and at least 2 years experience within the Parenteral Drug Product aseptic process development and/ or product process validation knowledge including technical terminology. Additionally 2-5 years of experience in technical writing is required, experience in writing of regulatory documents is of advantage..

Tasks & Responsibilities:
• Independently write, review and format process validation protocols and reports as well as regulatory documents
• Interpret and understand process validation data as needed to prepare respective documents
• Compile and organize the supporting data and documentation to ensure that accuracy, completeness, and consistency are maintained in the final PV package and regulatory documents (Compliance of internal and external documents)
• Work on multiple projects and/or project teams in parallel (dependent on complexity and time commitment for each project) ensuring timeline adherence in collaboration with project managers
• Coordinate assigned Process Validation (PV) study documents and regulatory submission dossier sections for project teams.
• Apply IT solutions/tools and act as "Superuser" to manage process knowledge and document workflow (e.g., Veeva Quality Docs, Veeva RIM, eVAL Roche, Basecamp2.0) in support of project teams

Must Haves:
• Bachelor's degree or Master's degree in a scientific discipline
• 2+ years experience within the Parenteral Drug Product aseptic process development and/ or product process validation knowledge including technical terminology
• 2-5 years of experience in technical writing experience in writing of regulatory documents is of advantage
• Excellent command of English is required
• Superior working knowledge and affinity to IT tool to manage text processing, flow diagram and spreadsheet applications as well as validation documentation workflows
• Ability to learn fast, grasp the 'essence' of a strategy or a story quickly to convert relevant scientific data/information into high quality summaries and reports
• Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects
• Ability to take high degree of initiative and demonstrates motivation to work independently and be a self-starter
• Team and solution oriented with flexibility in prioritization.

Reference Nr.: 924396SDA
Role: DP Parenteral Process Validation Technical Writer and Document Workflow Manager (m/f/d)
Industrie: Pharma
Workplace: Basel
Pensum: 100% (Home Office: 1 day per week)
Start : asap ( latest Start Date: 01.12.2025)
Duration: unlimited
Deadline: 11/09/2025

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.