Method & Engineering Manager
Method & Engineering Manager
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Job Description
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. Justs 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 Seattles South Lake Union neighborhood - the center of Seattles 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 Justs innovative platform and footprint - building our first North American commercial manufacturing facility in the Seattle job opportunities learn more at 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 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:
- Masters / 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 assets transition seamlessly from project mode to rock-solid operations accelerating access to biologics.
FR : Dans le cadre de sa politique Diversit Evotec tudie comptences gales 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.
Required Experience:
Manager
Employment Type
Full-Time
