Jobs for People with MS: National MS Society

Engineer Commissioning & Qualification - 2406192339W

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong

Johnson & Johnson is currently seeking a Engineer, Commissioning & Qualification to join our Engineering & Property Services (E&PS) department.

At Engineering & Property Services (E&PS) we take care of all J&J buildings around the world providing end to end services from Real Estate, Engineering & Strategic Project Delivery to Facilities Management. We have a profound influence on the entire J&J Enterprise, providing innovative workplaces where our employees can collaborate and grow, and delivering flexible site solutions which enable our business to best serve our important customers and patients.

The Engineer, Commissioning & Qualification is accountable for overseeing of C&Q capital project implementation strategy from Concept to Business Readiness, including aspects of project planning, training, resource management, execution logistics, close-out, document management, VTOP/TOTP handover and application of lessons learned.

This role is responsible for ensuring compliance with all applicable regulatory, J&J Quality standards and industry best practices in Capital Projects.

A suitable candidate for this role will have strong working relationships with partners (project delivery, quality, operation, system owner and tech. transfer) to ensure high quality deliverables meeting cGMP and site quality requirements. Will also be a self-starter with strong interpersonal, organizational, and technical skills with the ambition to have an impact to patients and J&J organization.

Key relationships include working closely with the regional Local teams of the different business segments, E&PS Project Delivery Teams, Project Controls, Engineering & Design, and the CoE within the strategic project delivery group.

Key Responsibilities

• Support C&Q workstream in the Project Delivery

o Drive the adoption of Risk Based Qualification in capital projects

o Drive the adoption of E2E C&Q Digital validation in capital projects

o Ensure alignment with J&J standards along with engineering methodologies and best practices

• Supports projects, in effectively scheduling, coordinating, mentoring and reviewing project activities with appropriate functional groups

o Support the setup of a project C&Q strategy and detailed plan

o Support the development of proposed C&Q schedule and start-up sequence (dependencies of systems), and resource loading

o Support and advice on set up of project change management program

o Support Engineering Document Control process and VTOP/TTOP handover

• Drive effective and efficient execution of C&Q program to deliver quality project outcomes meeting performance expectations

o Facilitate tactical C&Q workshops during capital projects to ensure alignment and identify gaps, then close gaps with project team as appropriate

o Facilitate project stage gate reviews for C&Q to ensure strategy is being implemented accurately and support issues as necessary

o Support commissioning and qualification phase advancement

o Review all capital project specific engineering C&Q documentation

o Monitor and evaluate contractor safety performance throughout the duration of the project

o Provide oversight to project contractors to ensure Site C&Q Program methods are being utilized per procedures

Qualifications

• Bachelor’s degree in Engineering or equivalent required

• FPX preferred

Experience, Skills & Knowledge:

Required:

• Excellent problem solving and troubleshooting abilities

• High level of familiarity with, Excel, Word, and Microsoft Project

Preferred:

• Knowledge of Digital Validation platform (Kneat)

• Experience with current commissioning and qualification methods, including ISPE, ICH, and Risk-Managed approach

• Knowledge of local regulatory requirements relevant to pharmaceutical and/or medical devices facilities

• Project management skills

• Prior experience in major capital (>10MM) projects

Language Requirements: Proficiency: English language

Travel Requirements: This position will require up to 50% domestic and international travel

Primary Location Europe/Middle East/Africa-Italy-Lazio-Rome

Other Locations NA-US-Pennsylvania-Horsham, Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, NA-US-Florida-Jacksonville, NA-US-New Jersey-New Brunswick, NA-US-New Jersey-Titusville, Europe/Middle East/Africa-Belgium-Antwerp-Geel, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Ireland-Cork-Cork, NA-US-New Jersey-Raritan, NA-US-Pennsylvania-Malvern

Organization Janssen-Cilag S.p.A. (7175)

Job Function Project Engineering

Req ID: 2406192339W