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Shire Purification Engineer I in Lessines (Baxalta), Belgium
The Purification Engineer I is responsible for design, construction/modification, commissioning and qualification of Purification/Clean Utilities systems according to EHS, GMP and Best Engineering Practices requirements.
Implicated in day to day manufacturing operations for problem solving/improvement deployement regarding purification and clean utilities systems.
- Projects: In scope of CAPEX programs and continous improvement of new/existing systems, the incumbent must be able to manage small engineering projects without assistance. In particular, the position implies :
Basic Design and support for budgets preparation
Detailed Design of new or modified systems
Tenders writing, orders handling, following of construction, and start-up of equipments
Writing and execution of validation packages (URS/FSDS/Commissioning/engineerin part of IQOQ)
Training of employees impacted by changes and new equipments
Ensure compliance to EHS, cGMP, regulatory and Best Engineering Practices requirements
Member of multidisciplinary project teams
Troubleshooting of equipment/systems: support day-to-day requests from purification manufacturing and maintenance, active participation in daily operational meetings with actions follow-up, handling troubleshooting change requests,..
Continuous improvement : Be on the floor to study and recommend improvement of existing equipments to minimize production down time. Provide suggestions on how to improve an existing equipment if needed
Expertise Development : Develop technical expertise on purification processes / Clean utilities systems.
Minimum Degree Required: University degree
Preferred Degree: Master
Certificate(s): Master degree in Engineering
- Two plus (2+) years of experience in a process engineering function within a biotech/pharmaceutical operations/ manufacturing environment. Knowledge of purification equipment & related clean utilities is required
KNOWLEDGE, SKILLS AND ABILITY:
Clean process/Clean utilities technical skills
Must have experience in project: design/construction/commissioning in a regulated environment.
Demonstrated experience in GEP, GMP and validation approach in pharmaceutical industrie
Working knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP)
Good communication, leadership and organizational skills
Must be a team player prepared to lead, work in, embrace a team based culture.
Client oriented, rigorous, synthetic and analytic thinking
Good written and verbal skills in French and English.
Must be proficient with standard office software (Word, Excel and PowerPoint)
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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.