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 responsibilities Document 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 cGMP 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 cGMP regulations.
Work Experience and Skills Required Essential Knowledge of current Good Manufacturing Practices (cGMP), 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.
Qualifications Essential Associate Degree, Vocational Training, or Bachelor's Degree Experience with Microsoft Office applications (Word, Excel, PowerPoint, Teams, Outlook, SharePoint) and database management tools such as Smartsheet.
Familiarity with cGMP 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.
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.
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 CapEx 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 baseline requirements and governance to drive consistency across engineering and facilities teams.
Investigate, develop, and recommend alternatives for design, procurement,



and installation of new/modified equipment or systems for the optimal utilization and control of resources.
Institute project teams and governance structures.
Lead and execute Site Master Planning across the segment.
Conduct troubleshooting and/or technical analyses on operational equipment and processes.
Establish Project Charters including scope of work, goals, and deliverables in collaboration with project champion/sponsor to support business objectives in alignment with senior leadership and key stakeholders.
Organize project governance requirements and subsequently coordinating communications and meetings in compliance with the governance.
Liaise with project stakeholders on an ongoing basis.
Ensures inclusion of Global Quality Tech Operations personnel in key decisions and project delivery efforts.
Ensures inclusion of Site Operations (Manufacturing, Engineering, Quality, Validation, etc) personnel in site related projects and continuous improvement efforts.
Developing metrics to manage, evaluate, and communicate progress on assigned tasks, projects, improvement efforts, etc.
Leads the implementation of major capital projects as needed.
Provide technical support through the gate process, during pre-construction phase, and coordinate daily activities with the production area and project management and contractors.
Prepare URS, Risk Assessments, Safety Assessments associated with the project.
Leads the effort with end users to develop system requirements, specification of equipment/buildings, review design from outside engineering firms or contractors (as needed), overseeing fabrication and leading Factory/Site Acceptance Testing.
Ensure risks to employee health and safety are rigidly controlled in compliance with the PCI PHARMA SERVICES Environmental Health and Safety procedures.
Act as a champion and change agent in support of the Integral Engineering team and other continuous improvement efforts.
Project Management Professional (PMP) certification or similar accreditation is required.
Masters degree in Engineering preferred Preferred A minimum of 15 years experience in cGMP related engineering, facilities clean utilities and/or plant utilities, preferably in the biotechnology, medical device, or pharmaceutical industry.
A minimum of 10 years experience in a life science contract, development, and manufacturing Organization (CDMO) environment.
A minimum of 5 years people supervision and management experience.
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 #J-*****-Ljbffr

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