Engineering Project Manager (Facilities)
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
- The Facility Engineer is responsible for managing all phases of equipment projects including but not limited to the design, user requirements and specifications, installation, modification, testing, and turnover of facilities equipment, systems, and utilities that support manufacturing, packaging, formulation, and analytical development.
- In addition, they are responsible for managing technical engineering documents such as SOPs, standards, drawings, turn over packages (ETOPs), etc.
- This role reports into the Senior Director Site Engineering and works within cross-functional teams to support multiple business functions.
Main tasks and responsibilities will include:
- Maintain a safe, compliant, and professional work environment.
- Act as engineering (SME) for all internal stakeholders, contributing to purchase decisions of assets and during the entire equipment lifecycle, from design qualification, to release of the asset into service to decommissioning.
- Manage and maintain engineering technical standards, procedures, and documentation, and turnover packages as it relates to both GxP and non-GxP equipment, facilities, systems, & infrastructure (i.e., drawings, specifications, etc.) that meet or exceed regulatory compliance, adopt industry best practices, and adhere to applicable local and global procedures.
- Manage and execute multiple projects of varying sizes and complexities including but not limited to facility remodels, equipment, system, or utility installations or modifications, and various capital (CAPEX) projects.
- Develop project plans, set objectives, determine key deliverables or milestones, and track progress against the critical path (i.e., time, budget, resources, etc.)
- Identify team members, project roles and responsibilities (RACI matrix, project charters, etc.).
- Manage, schedule, and coordinate contractors, vendors, OEMs as required.
- Develop, maintain, and report against timelines and milestones to leadership and key stakeholders (gantt charts, etc.).
- Support routine client and regulatory inspections by providing documents, responses and/or positions as required.
- Maintain a state of audit readiness including but not limited to equipment
- Performs other related duties as required and assigned.
- University Bachelor’s degree required. (B.S. in Industrial, Mechanical, Electrical, Chemical engineering, validation, or equivalent).
- M.S. degree in Engineering preferred. (i.e., Industrial, Mechanical, Electrical, Chemical engineering).
- Significant experience related to facilities, maintenance, and/or engineering processes within a regulated industry required (i.e., food, beverage, nuclear, pharmaceuticals, etc.).
- Pharmaceutical or similar experience preferred.
- Oral Solid Dose (OSD) Manufacturing experience is highly desired.
- Demonstrated understanding of engineering principles including electrical, mechanical and safety systems is required.
- Required proficiency in project management, including obtaining agreement on project definitions and priorities from business stakeholders, and ensuring that resources, capabilities, and processes are in place to deliver the project efficiently and effectively.
- A very skilled project leader, with the understanding of how to develop bridges between disciplines, functions at various level.
- Experience driving continuous improvement initiatives to deliver enhanced business and quality results.
- Lean Six Sigma background - green belt, preferred
- Professional memberships, certifications, or licenses are preferred (i.e., AFE, IFMA, ISPE, NSF, PMI, or similar)
- Knowledge of design and manufacturing practices in highly regulated environment such as pharmaceuticals (GMP, GxP), food processing (HACCP) or electronic industry.
- Oral solid dose (OSD) manufacturing preferred.
- Proficient verbal and written communication skills in English is required.
- Proficient use of standard Microsoft software is required (i.e., Microsoft Office, Word, Excel, PowerPoint, Teams, etc.).
- Experience with additional Microsoft applications is preferred (i.e., Microsoft Project, Visio, etc.).
- Practical CAD experience desired for simple red lines and drawing corrections.
- Experience using TurboCAD or equivalent preferred.
- Critical thinking, complex problem solving, and data analysis.
- Teamwork and relationship building mindset with the ability to form strong connections to clients and personnel.
- Agile leader with the ability to manage a team of individuals in a fast-paced environment.
- Ability to work independently and within cross-functional teams both locally and globally.
- Multitasking skills with the ability to manage a range of tasks and issues simultaneously.
- Time management skills with the ability to manage strict and tight deadlines
In return, you will receive a competitive salary, a generous benefits package, excellent training, and development, as well as an exciting career within a fast-paced and dynamic business.
Our Commitment to Diversity & Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion.
We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.
As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.
If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at firstname.lastname@example.org.