Shire Plant/Process Engineer in Neuchatel, Switzerland
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmic, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology. In 2016, Shire grew its organization to approximately 23,000 employees+ globally, following integrations of Dyax and Baxalta.
An exciting and challenging opportunity has become available at Shire Neuchâtel Plant (approx. 650 employees) for an experienced Plant/Process Engineer to join our Site Engineering team.
As Plant/Process Engineer, your mission will be to supply engineering expertise to support and continually improve the Shire Neuchatel site and ensure the continued production activities while respecting all relevant standards, cGxP's, and the wants and needs of the customer.
Essential Duties & Responsibilities
The Plant Engineering team with the Site Engineering department ensures continuous support for the Shire Neuchatel site installation.
As the equipment & process expert, it is Plant Engineering who is providing the technical support for the user with respect to investigations, re-occurring problems, required modifications, optimizations and Continuous Improvements.
Additionally, the Plant Engineer shall support the delivery of projects of varying complexity that span the complete site operations and organizational boundaries.
As Plant Engineer, your primary area of activity will be Bulk Production areas, with
support to the Utilities, Facilities and Aseptic Filling areas.
The Plant Engineer shall :
Be the primary contact (Subject Matter Expert SME) for the users of the assigned installation with regard to technical aspects.
Provide expertise in systems and production equipment such as Bioreactors, Filtration (icl UFDF), Chromatography, Process piping systems, CIP skids, SIP systems.
Provide expertise on the link between the production equipment and support equipment such as WFI, Clean Steam, Process Gases, HVAC, and Building Utility Systems.
Provide Support to the Utilities and Facilities
Provide Support to the Fill Finishing plant engineer regarding Aseptic Filling equipment, Freeze Dryers(Lyophilisers) and sterile filtration.
Lead &/or Supports the design, installation, commissioning and qualification of improvements, changes or upgrades to the equipment/plant.
Ensure proactively that the technical condition of the equipment, systems and installations are appropriate for use, proposing corrective actions and/or improvements to the user in case of weaknesses.
Is organizing and coordinating corrective actions, improvements and modifications.
Ensure compatibility and consistency with existing organization and industry standards (cGMP, GEP, SUVA/ASIT etc.)
Ensure that appropriate safety measures are taken to prevent all risks of injury
Develop and applies engineering procedures and company standards.
Ensure implementation of site, divisional and corporate procedures.
Participate in internal and external audits as a system expert.
Lead the Shire Obsolecense programme
Engineering degree (BS, MS or equivalent) in biotechnology, chemistry, food processing and/or mechanical engineering.
7+ years experience in the Pharma/Biotech industry (Process/Engineering and/or Manufacturing).
Experience in the installation, commissioning and validation of pharmaceutical facilities, utiltities and process equipment equipments as per the following:-
Process piping & instrumentation
Bioreactors, process vessels and storage tanks
Chromatography and filtration (incl filter testing) units
CIP Systems and processes
SIP Systems and processes
Clean steam and WFI systems
Clean room design and operation incl room monitoring systems
HVAC design is an asset
Experience with Six Sigma/DMAIC investigation techniques
Knowledge of Good Engineering Practices, cGxPs, FDA guidelines, ISPE guidelines, ATSM E2500 & ASME/BPE standards.
French and English (spoken and written),
PLC/Automation (Siemens & Allen Bradley) programming experience an asset.
Computer skills: MS-Office suite and MS-Project and/or Primavera
Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:
Be Results Oriented
Be An Excellent Manager of Self and Others
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.