Method & Engineering Manager

About Just – Evotec Biologics

Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 100+ employees is expanding Just's innovative platform and footprint - building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers

Just-Evotec Biologics is seeking a highly motivated Methods and Engineering Manager of Facilities & Engineering that desires a significant opportunity to improve worldwide access to biotherapeutics.  The candidate will be managed by the Head of Engineering and Facilities. The primary focus of this job is to help and optimize the Facilities & Engineering (F&E) functions for both GMP Biologics Manufacturing and QC laboratories and Process Development Laboratories at Just-Evotec Biologics state of the art J.POD™ Facility, located in Toulouse, France. This highly qualified candidate will collaborate with the Head of Engineering and Facilities and partner with Manufacturing Operations, Technical Operations, Quality Assurance, Quality Control, Materials Management, Process Development and EH&S functions to ensure regulatory compliance and optimal functioning of all manufacturing, laboratory, and building spaces. The candidate will propose solutions and tools to follow for the daily activities, KPI, and the breakdown (annual or for punctual intervention)

Additional F&E responsibilities for GMP biologics manufacturing sites will be to the candidate. This includes the implementation and maintenance of Computerized maintenance management system including optimization (KPI, schedule to develop, optimization schedule activities, defined the categories of priorities spare parts). Manage investigation with lean methodology, define the action plan and to follow, prepare the change control and other F&E investigation

Your challenge is two-fold:

Run the plant today — reliability, utilities, shutdowns, compliance. Prepare the plant for tomorrow — by partnering with CP to make sure every new asset is designed, commissioned and handed over ready for steady-state operations.

Educational Requirements:

• Master’s / Engineering degree and 10 + years in GMP biopharma or similar; ≥ 5 years team or project leadership.
• Expert in GMP utilities & CMMS; Lean/Six-Sigma Green/Black Belt welcomed.
• Fluent English & French; proven stakeholder skills across operations, CP, MSAT, CQV, Quality.

Qualification Requirements:

• Knowledge of  utilities systems, including but not limited to HVAC, WFI, pure steam, clean compressed air, process gases, chilled water, boilers, and wastewater treatment
• Subject matter expert representing and defending GMP systems in audit settings
• Experienced in the use of electronic systems such as QMS and CMMS.
• Previous experience managing the activities of individuals, work groups, and project teams.
• Candidate must possess strong focus on quality and attention to detail
• Cross-functional management skills
• Manage and deploy the tools of investigation, lean manufacturing tools such as Ishikawa, Six Sigma, 5W2H, manage CMMS data & KPIs (MTBF, OEE, water/energy).
• Certification Lean Six Sigma (Green or Black Belt) this would be an asset 
• Motivated, self-starter with strong mechanical aptitude
• Good interpersonal, team, and communication skills are a must

• Excellent oral and written communication skills
• Strong computer skills include Microsoft Office (Word, Excel, Power Point, and MS Project, Smartsheet)

Responsibilities:

• Work with different teams across the operational organization (including facilities and engineering, manufacturing, MSAT, CQV, Quality, etc) to identify and analyze complex problems within the organization. 
• Propose innovative and effective solutions to challenges. 

• Collaborate with different teams to implement improvement strategies. 

• Collect and analyze data to support decisions and recommendations. 

• Present reports and recommendations to relevant stakeholders. 

• Manage multiple projects simultaneously and meet deadlines. 
• Manage the team in cross-functional, engineers, planners & techs; build skills matrix & succession.

• Follow up on implemented solutions to assess their effectiveness 

• Adapt tools and KPIs to follow the resolution of the problem 

• Adapt quickly to new situations and unforeseen challenges. 
• Technical shutdown : with the involvement of the facilities and engineering CMMS planner, this role will be in charge of all planning aspects of the annual technical shutdown and optimization of the cross-functional tasks involved in the technical shutdown.

• For the shutdown allocation of resources (human, technical, etc.) according to the objectives set for F&E, MSAT, CQV activities 

• Prepare a global and day to day schedule using project management best practices 
• Lead the internal meeting for activities and cross functional meeting

• Work closely with the CMMS planner to manage the activities in the system, charge, duration, etc 

• Collect and analyze progress data and draw up dashboards and monitor indicators to facilitate decision-making. 

• Define with the planer to shutdown analysis and feedback. 

• Capital-Project Collaboration & Handover

• Embed F&E lifecycle requirements in CP charters and URS.
• Sit on CP steering committees; provide cost/time/risk input.
• Lead F&E reviews of design, FAT/SAT, commissioning & CQV.
• Coordinate joint “Ready-for-Handover” checklists (docs, spares, SOPs, training).
• Accept systems into CMMS and KPIs; organise post-start-up support with CP.

• Manage the Risk assessment, define the action plan
• Manage investigation with lean methodology, define the action plan and to follow, prepare the change control and other F&E investigation
• Optimize task, time and cost for maintenance activities with each manager of the F&E

Why This Role?

• Impact – Ensure our next-generation J.POD® assets transition seamlessly from project mode to rock-solid operations, accelerating access to biologics.

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.