Principal Engineer, Global Technical Operations, Engineering & Innovation

PCI Pharma Services; León; On-site; EUR 85,000 - 120,000; Full time

Job summary

PCI Pharma Services in León, Spain, seeks a Principal Engineer to lead Global Technical Operations, Engineering & Innovation, providing SME guidance on sterile fill finish and lyophilization systems and managing cross-functional teams for FEED and project governance.

The role demands extensive cGMP experience, strong leadership, and ability to collaborate with Senior Leadership to standardize practices, drive capital projects, and advance Lean improvements across the segment.

Qualifications

• BS in Chemical, Mechanical, or other Engineering from an accredited university.
• PMP certification or similar accreditation.
• Masters degree in Engineering preferred.
• 15+ years in cGMP engineering, facilities clean utilities, or related field.
• Experience in aseptic processing and lyophilization highly desirable.

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.
• Lead site Master Planning and Manufacturing Asset Assessments.
• Lead and execute Site Master Planning across the segment.
• Prepare URS, Risk Assessments, Safety Assessments associated with the project.
• Leads the effort with end users to develop system requirements and oversee design reviews with external firms when needed.
• Organize project governance requirements and coordinate communications with stakeholders.
• Promote Lean Manufacturing and Continuous Improvement across the organization.

Education

BS in Chemical, Mechanical, or other Engineering degree

PMP certification

Masters degree in Engineering

Job description

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.

Principal Engineer, Global Technical Operations, Engineering, & Innovation

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. 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:

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.

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

Equal 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.