Shire Fill & Finishing plant Engineer I in Lessines (Baxalta), Belgium
Responsible for providing day to day and projects equipment engineering support for Filling & Finishing manufacturing systems.The incumbent will be responsible for executing and adhering to pharmaceutical change control standards and policies. The engineer is required to spend fifty percent (50%) of his/her time on the floor and will provide techniques to improve existing equipment to minimize cost and increase efficiency. Support all equipment related investigations and new equipment implementation.
Essential Duties & Responsibilities
Ability to prioritize multiple tasks from multiple customers.
Be on the floor to study and recommend techniques to improve existing equipment to minimize production down time. Provide suggestions on how to improve an existing equipment if needed.
Determined basic causes and develop recommendations for corrective action, and follow-up to ensure completion of corrective action.
Perform troubleshooting on plant equipment and systems.
Investigate and analyze customer service problems and design improvement suggestions. Recommend design improvements through adaptations and modifications of standard technical principles.
Ability to manage routine small tasks/projects without assistance.
Ability to work on project implementation and to write qualification documentations (UFSDS...)
Must have good verbal/written communication skills.
Must be proficient with standard office software, such as Word, Excel and PowerPoint.
Must be able to navigate, conduct searches, and fill on line forms on Personal Computer for the purposes of training, performance management, and self-service applications.
Must have the ability to navigate electronic mail systems and intranet for communication purposes.
Good interpersonal skills and be able to work effectively and efficiently in a team environment.
Experience in pharmaceutical, biotechnology or related field is preferred.
Knowledge of basic pharmaceutical production equipment including but not limited to: filling line, autoclaves and CIP/SIP systems is preferred.
Working knowledge of current Good Manufacturing Practices (cGMP), and current Good Documentation Practices (cGDP) is preferred.
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
Education and/or Experience
A minimum of a Bachelor’s degree in engineering with at least 3 years related experience in a GMP pharmaceutical environment. Master degree is preferred.
Solid experience with fill machine, Isolator, lyophilisator, Robots, Autoclaves CIP and SIP skids is preferred
- Work in controlled or clean room environments requiring special gowning. Will be required to follow gowning requirements.
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.