Engineering Project Manager - Senior
ProClinical is advertising a vacancy for a Senior Specialist, Regulatory Affairs position with a major biotechnology company that prides itself on its extensive pipeline and commercial portfolio in oncology and immunology. The position is with the company's office in Liverpool. This is an exciting opportunity to join an innovative company that delivers life-changing drugs with over 4000 employees in over 50 countries worldwide.
- Providing or coordinating project management services for engineering and facility projects *
- Delivering project End-to-End, i.e. from shaping the idea, through capital appropriation, various design stages and subsequent execution as well as commissioning or qualification and final handover to the user.
- Applying state-of-the-art Project Management Standards.
- Providing subject matter or process expertise.
- Using technical knowledge of equipment and facilities maintenance systems as well as calibration standards, tooling processes, and documentation control systems in a regulated manufacturing environment.
- Establishing a high performing team to deliver defined scope.
- Preparing routine status and progress reports.
- Leading the specification of functional and technical requirements and supporting Procurement in negotiations with contractors and vendors.
- Establishing effective project planning and cost control (incl. hours).
- Leading lesson learned workshops and fostering organizational learning Examples of current/recently implemented projects:
- Replacement of the material air look -
- Revamp/modernization of an old AP system -
- Extension/adaption of the existing cooling loop for a 2nd lyophilization line -
- Installation of a new waste water inactivation system in including adaption of the technical area -
- Retrofit deco autoclave, Retrofit escape door seals -
- Additional installation for the HVAC for dehumidification -
- Extension / expansion of a laboratory including installation of gas media -
- Final activities on separation of media in the building -
- Get quotes for 2 new canteen equipment
- Organising and directing multi-disciplinary teams effectively towards the project goal.
- Insuring a safe working environment, esp. during construction and installation phases acc. to local EHS&S Guidelines.
- Supervising construction and machine installation.
- Communicating effectively and unambiguously toward team, management, and suppliers.
- Responsibly staying within assigned project budgets and timelines as well as defined deliverables.
- Project-related supervision on GMP, EHS and SOx-compliance matters.
Skills and Requirements:
- Master's degree or advanced diploma in pharmaceutical or related engineering studies (mechanical, chemical engineer etc.).
- Track record of at least eight years' experience in the biotechnology, pharma, food or nuclear industry, with proven experience in the engineering field.
- Project Management Certification preferred, knowledge of J&Js FPX methodology is a plus.
- A thorough knowledge of cGMP regulations pertaining to operation and maintenance of machinery and facilities.
- Fluency in English and German is a must.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Caleb Mensah at +44 203 854 1080 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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