Position Title:Upstream Operations Documentation SpecialistContract Type:Fixed Term Contract – 12 MonthsLocation:Dublin – Hybrid (4 days onsite, 1 day remote after initial training)Start Date:ASAPWorking Hours:Day role (no shifts)Industry:Leading Pharmaceutical Manufacturing CompanyRole OverviewAn excellent opportunity has arisen for anUpstream Operations Documentation Specialistto join a leading pharmaceutical manufacturing organisation.This role provides key operational support to the Upstream Manufacturing team, ensuring right-first-time batch execution and compliance with quality and safety standards. The position will initially befully onsiteduring the training phase and will transition to ahybrid model(4 days onsite, 1 day remote).The successful candidate will play a pivotal role in the production of biologics-based medicines, supporting operational excellence and continuous improvement across manufacturing activities.Key ResponsibilitiesSupport the Integrated Process Team (IPT) to ensure effective, efficient, and on-time delivery of upstream batch production.Drive process reliability and operational excellence across Upstream Operations.Coordinate daily production activities and support achievement of key KPIs (EHS, production plan, compliance, training).Manage and track the creation and updates of Standard Operating Procedures (SOPs) and Work Instructions (WIs) for new product introductions.Own and manage CAPAs, ensuring timely closure and documentation accuracy.Support material management processes within Upstream Operations.Perform data analysis to support operations in areas of safety, quality, delivery, and cost.Collaborate with Finance for monthly material usage reporting and approvals.Liaise with key stakeholders, including Operations, Technical Operations, and Quality Assurance.Collect and analyse downtime data to support root cause investigations and problem-solving.Provide communication updates to manufacturing shift teams.Coordinate and support audit activities, including preparatory documentation.Manage contractor and visitor coordination within the Biologics Drug Substance area.Required Skills and ExperienceProven working knowledge of SAP .Experience with Qualified Document Management Systems (QDMS) .Strong organisational and time management skills with a proactive approach.Ability to work both independently and collaboratively with cross-functional teams.Proficiency in MS Office Suite (Word, Excel, PowerPoint) to generate reports and metrics.Excellent written and verbal communication skills.Desirable SkillsWorking knowledge of Upstream bioprocess operations is highly desirable.Familiarity with Lean Six Sigma and continuous improvement methodologies.Understanding of GMP and regulatory compliance in a manufacturing setting.EducationBachelor's degree (or higher) in Science, Engineering, or a related discipline .Why JoinThis is a fantastic opportunity to contribute to a world-class biopharmaceutical manufacturing environment focused on innovation, quality, and patient impact. You'll collaborate with a diverse and inclusive team dedicated to continuous improvement and operational excellence.