Leon, Spain

Full time

JR

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 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.
- Documentation Issuance - Generate and issue forms, templates, labels, logbooks, and documentation associated with R&D; trials, equipment runs, engineering batches, manufacturability studies, and pre-stability studies.
- 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.
- Protocol and Report Preparation - Prepare simple protocols, reports, and controlled documents using approved templates and departmental standards.
- 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.
- Personnel Administration - Support onboarding and offboarding activities for R&D; personnel and maintain associated administrative records.
- Procurement and Shipment Coordination - Manage purchasing requests, monitor purchase orders, coordinate receipt of materials and samples, and organize R&D; shipments, including samples and development materials.
- Continuous Improvement - Identify opportunities to improve documentation workflows, administrative processes, and departmental practices to enhance efficiency and compliance.
- 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.
- Demonstrated ability to manage multiple administrative tasks simultaneously while maintaining a high level of accuracy and attention to detail.
- Strong organizational, communication, and interpersonal skills with the ability to interact effectively across multiple departments.

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.
- Honesty, integrity, respect and courtesy with all colleagues.
- 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.
- Resilient through operational and organizational change.
- Ability to work in a dynamic, fast-paced work environment.

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

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.
- At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level.



We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business;
we don't say no, we figure out how.

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.

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.

Overview

The Principal Engineer (Integral 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. Responsible for driving segment level standardization of engineering and facilities approaches, tools, ways of working, Lean Manufacturing, and Continuous Improvement. Supports master planning, manufacturing asset assessments, and 5 year CapEx planning across the segment in alignment with enterprise priorities. Provides engineering mentoring to Site engineering teams in collaboration with engineering management.

Essential Duties and Responsibilities

- Be Subject Matter Expert (SME) in isolated or RABS sterile fill finishing and lyophilization equipment and operations.
- 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.
- Drive standard work creation and process documentation discipline.
- 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 Manufacturing Asset Assessments across the segment.
- 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.
- Drive a culture of Lean Manufacturing and Continuous Improvement at all levels within the organization through the use the site maturity index.
- 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.
- Demonstrate the ability to engage, motivate and positively influence others in the pursuit of achieving PCI goals.
- Supports safety through personal engagement and promote individual accountability for safety across the operational segment. 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 Global Engineering team and other continuous improvement efforts. Effectively support internal and external relationships, key stakeholders, vendors. Strong communication skills

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required

- BS in Chemical, Mechanical, or other Engineering degree from an accredited university is required.
- 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.
- A minimum of 5 years experience working in procurement environment exhibiting negotiation skills and bidding/proposal evaluation leading to decisions on vendor selection.
- A minimum of 5 years experience with continuous improvement and hands on innovation ideation platforms.
- Must have experience in aseptic processing.
- Experience with aseptic liquid filling of vials, cartridges, and syringes under isolated and RABS environments;
aseptic lyophilization;
and aseptic processes, including refrigerated and frozen capabilities.

#LI-CW1

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

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.
- At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business;
we don't say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

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