Project Engineer - Switching Devices

Ul, Llc; Meira; On-site; EUR 107,000 - 161,000; Full time

Job summary

PCI Pharma Services seeks a senior Principal Engineer to provide SME-level leadership in sterile fill finishing and lyophilization equipment, driving Front End Engineering Designs, and coordinating cross-functional teams in a CDMO environment. You will support project governance, cost evaluation, and master planning for the segment.

The role requires extensive GMP experience, strong engineering leadership, and the ability to lead complex capital projects across global sites.

Qualifications

• BS in Chemical, Mechanical, or other Engineering degree is required.
• Project Management Professional (PMP) certification or similar accreditation is required.
• Masters degree in Engineering is preferred.
• 15+ years of experience in cGMP-related engineering, facilities and/or life sciences industries is preferred.

Responsibilities

• Be Subject Matter Expert (SME) in isolated or RABS sterile fill finishing and lyophilization equipment and operations.
• Manage Front End Engineering Design efforts to develop project scopes, cost estimates and schedules.
• Lead external engineering partners and internal cross-functional teams in FEED projects.
• Develop and implement segment-level engineering standards and governance for consistency across teams.
• Lead site Master Planning and Manufacturing Asset Assessments across the segment.

Education

BS in Chemical, Mechanical, or related Engineering

Job description

Make an impact with NTT DATA

Join a company that is pushing the boundaries of what is possible. We are renowned for our technical excellence and leading innovations, and for making a difference to our clients and society. Our workplace embraces diversity and inclusion - it's a place where you can grow, belong and thrive.

Your day at NTT DATA

The Networking Remote Field Service Engineer (L1) is an entry level engineering role, responsible for operating in region and provides a professional remote technical support service to clients by identifying and resolving technical incidents and problems. Through pre-emptive service incident and resolution activities, this role will restore service to clients by driving incidents to an effective resolution and ensuring all requests, process events and resolution incidents result in zero missed service level agreement (SLA) conditions.

Key responsibilities

• Maintains the support process and ensures that requests for support are handled according to the procedures.
• Uses service assurance software and tools to investigate and diagnose problems, collects performance statistics and creates reports, working with users, other staff and suppliers as appropriate.
• Identifies and resolves problems following agreed procedures.
• Carries out agreed maintenance tasks.
• Ensures usage of knowledge articles in incident diagnosis and resolution and assist with updating as and when required.
• Performs defined tasks to monitor service delivery against service level agreements and maintains records of relevant information.
• Analyses service records against agreed service levels regularly to identify actions required to maintain or improve levels of service, and initiates or reports these actions.
• Prioritizes and diagnoses incidents according to agreed procedures.
• Investigates causes of incidents and seeks resolution.
• Escalates unresolved incidents and follows up until incident is resolved.
• Provides service recovery, following resolution of incidents.
• Documents and closes resolved incidents according to agreed procedures.
• Maintains secure, accurate, complete, and current configuration on configuration items (CIs).
• Applies tools, techniques and processes to track, log and correct information related to CIs, ensuring protection of assets and components from unauthorized change, diversion, and inappropriate use.
• Remotely investigates and identifies root cause of incidents and assist with the implementation of agreed remedies and preventative measures.
• Maintains knowledge of specific specialisms, provides detailed advice regarding their application.
• Ensures efficient and comprehensive resolution of incidents, including ensuring that repairs are carried out by coordinating product requests, working with other team members.
• Provides continuous feedback to clients and affected parties and update all systems, portals and ticketing tools as prescribed by standard operating procedures.
• Identifies problems and errors prior to or when they occur.
• Logs all such incidents in a timely manner with the required level of detail with all the necessary.
• Cooperates with all stakeholders including client IT environments, vendors, carriers and colleagues to expedite diagnosis of errors and problems and to identify a resolution.

Knowledge, Skills and Attributes

• Ability to communicate and work across different cultures and social groups.
• Ability to plan activities and projects well in advance and takes into account possible changing circumstances.
• Ability to maintain a positive outlook at work.
• Ability to work well in a pressurized environment.
• Ability to work hard and put in longer hours when it is necessary.
• Ability to apply active listening techniques such as paraphrasing the message to confirm understanding, probing for further relevant information, and refraining from interrupting.
• Ability to adapt to changing circumstances.
• Ability to place clients at the forefront of all interactions, understanding their requirements, and creating a positive client experience throughout the total client journey.
• Entry level knowledge of vendor technologies, such as (but not limited to) Cisco, Juniper, Aruba, RiverBed etc.
• Entry level knowledge on management agent concepts, redundancy concepts and remote console architecture within supported technical domain.

Academic qualifications and certifications

• Bachelor's degree or equivalent in Information Technology or Computing or related field.
• Associate level certification in different Networking technologies such as (but not limited to) Cisco, Juniper, Aruba, F5, CCNA, JNCIA, ACMA etc.

Required experience

• Entry level experience in Networking technologies such as routing, switching, Wireless, SDI distribution, core and access layers.
• Entry level experience in technical support to clients.
• Entry level experience in diagnosis and troubleshooting.
• Entry level experience providing remote support in Networking technologies.
• Entry level experience in relevant technology.

Workplace type

Remote Working

About NTT DATA

NTT DATA is a $30+ billion trusted global innovator of business and technology services. We serve 75% of the Fortune Global 100 and are committed to helping clients innovate, optimize and transform for long‑term success. We invest over $3.6 billion each year in R&D to help organizations and society move confidently and sustainably into the digital future. As a Global Top Employer, we have diverse experts in more than 50 countries and a robust partner ecosystem of established and start‑up companies. Our services include business and technology consulting, data and artificial intelligence, industry solutions, as well as the development, implementation and management of applications, infrastructure, and connectivity. We are also one of the leading providers of digital and AI infrastructure in the world. NTT DATA is part of NTT Group and headquartered in Tokyo.

Equal Opportunity Employer

NTT DATA is proud to be an Equal Opportunity Employer with a global culture that embraces diversity. We are committed to providing an environment free of unfair discrimination and harassment. We do not discriminate based on age, race, colour, gender, sexual orientation, religion, nationality, disability, pregnancy, marital status, veteran status, or any other protected category. Join our growing global team and accelerate your career with us.

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.

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 utilisation 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.
• Organise 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.

#LI-CW1

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.

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