Leon, Spain Full time JR Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. 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 responsibilitiesDocument Management and Control
- Organize, scan, archive, and maintain R&D; department documentation. Ensure document traceability, version control, template management, and compliance with internal procedures and GMP requirements. Data Management and Reporting
- Create, maintain, and update departmental databases and tracking tools using Smartsheet, Excel, and other systems. Compile data generated during trials and batches and prepare process charts, reports, and graphical trend analyses. Change Control Support
- Coordinate and manage basic document-related change controls and support documentation updates in collaboration with project team members.
Production Data Collection and Analysis
- Obtain and compile primary data from manufacturing equipment in accordance with c GMP requirements and internal PCI procedures. Generate process monitoring charts and supporting documentation. Training Administration
- Monitor training compliance within the R&D; department and support the creation, maintenance, and filing of training records.
Compliance
- Maintain knowledge of and comply with all company policies, internal procedures, quality standards, safety requirements, and applicable c GMP regulations. Work Experience and Skills Required Essential Knowledge of current Good Manufacturing Practices (c GMP), documentation management principles, data integrity requirements, and pharmaceutical development processes.



Communications & Contacts Works directly with R&D; management, scientists, technicians, and project teams. Works closely with Quality Assurance, Quality Control, Supply Chain, Operations, Human Resources, Purchasing, and Project Management departments.
Coordinates with internal stakeholders regarding documentation, training, materials, procurement activities, and change controls Ability to work independently and collaboratively within a multidisciplinary pharmaceutical development environment.
QualificationsEssential Associate Degree, Vocational Training, or Bachelor's Degree Experience with Microsoft Office applications (Word, Excel, Power Point, Teams, Outlook, Share Point) and database management tools such as Smartsheet. Familiarity with c GMP documentation practices and document control systems is highly desirable. Creative with the ability to work with minimal supervision and balance with independent thinking. At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled Principal Engineer, Global Technical Operations, Engineering & Innovation Bedford, NH, USA Leon, Spain Full time JR Life changing therapies.
Integral impact. Bridge to thousands of biopharma companies and their patients. 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.
Overview The Principal Engineer (Global Technical Operations, Engineering & Innovation), acting as a subject matter expert, provides oversight in the design of state of the art isolated sterile fill finish and lyophilization equipment and supporting plant systems through direct involvement and/or managing a cross functional team, supports fine tuning and continuous improvement objectives in assuring equipment or systems operate at optimal performance. The Global Principal Engineer is responsible for providing technical leadership and management in the delivery of Front End Engineering Designs which includes cross functional collaboration to develop Project Charters, Project Scope Definitions, Project Business Requirements (business case), and economic evaluations needed to support project approvals, stage gate reviews, project governance, etc. This position requires ability to interact and galvanize input through all levels of the organization including Senior Leadership and C Suite.
Supports master planning, manufacturing asset assessments, and 5 year Cap Ex planning across the segment in alignment with enterprise priorities. Manages Front End Engineering Design efforts to develop project scopes, cost estimates, and schedules in accordance with identified project priorities and business objectives providing deliverables for the foundation of business case evaluations in a CDMO environment. Manages external engineering partners and internal cross functional teams in the execution and delivery of Front End Engineering Designs Develop and implement segment level engineering standards, establishing clear baseli

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