Shire Sr Engineer II - Tech Transfer in Lexington, Massachusetts
Reporting to the Head of Site Technical Services, the Senior Engineer II-Technical Transfer will help lead a group for new product introduction into Shire Lexington manufacturing. The key deliverables for this function include:
•Managing the Shire Lexington SiteTech Transfer projects for all clinical and commercial products, acting as a technical leader in guiding a cross-functional project team to meet project timeline.
•Quality system management to support tech transfers, supporting Manufacturing Continuous Improvement initiatives.
The Senior Engineer II-Technical Transfer is responsible for driving the organization towards a culture of collaboration, accountability, accuracy, and efficiency. The primary objectives are to ensure effective management of tech transfers, timely execution of deliverables related to tech transfers, identification and application of best practices between product transfers. Additionally, the Senior Engineer II-Technical Transfer may be responsible for supporting the Technical Services function as required including project management and routine documentation support as well as supporting preparation of CMC sections and components of regulatory submissions for new and marketed products in collaboration with relevant function areas and teams. Lead projects of various complexities to support departmental initiatives and participate in various cross-functional teams to support process improvements.
80% of Time
Tech Transfer Process
Lead or participate in tech transfer process:
•Work with tech transfer teams, PDTS teams, Manufacturing, and other stakeholders to clearly define scope of work, objectives, and deliverables for tech transfer sub-teams.
•Ensure that cross-functional teams are identified and established for transfers and timelines are properly managed in order to meet deliverables and expectations
•Work to establish and revise procedures / best practices forstandardized transfer processes
•Routine reporting of progress and status of transfers to management.
•Ensure documentation support is provided for continuous improvementprojects and tech transfers.
•Effectively communicate ideas, project goals, and results.
•Foster teamwork and drive project/process improvements.
•Expected to lead cross functional projects and teams
20% of Time
Routine Operational Support
•Lead or participate in Implementation of CAPAs and change controls inresponse to investigation findings and process improvement initiatives.
•Actively develop, support and manage projects / activities as they relateto Manufacturing operations / processes
•Identify and schedule project events around manufacturing operations
•Communicate events effectively to the Scheduler and impacted groups
EDUCATION AND EXPERIENCE REQUIREMENTS
•BS/MS Degree in Science, Engineering or related pharmaceutical field. (or an equivalentcombination of education and relevant experience)
•Ten years in experience in Pharmaceutical, biotech product development or commercial manufacturing operations.
•Proven record of technical leadership, including ability to influence, motivate, and drivetechnical rigor.
•Project management experience and demonstrated ability to manage large cross functionalteams
Key Skills, Abilities, and Competencies
Strong technical leadership and direct experience in tech transfer of biopharmaceuticalproducts
•Must possess knowledge of cGMP and commercial operations.
•Effective verbal and written communication skills throughout all levels of the organization.
•Proven organizational and time management skills
•Customer service oriented
•Ability to foster a collaborative mindset with teams
Defining and managing detailed timelines for simultaneous cross-functional efforts
•Prioritization of deliverables from complex projects
•Intimate understanding of manufacturing capabilities
•Ability to understand technical details and product specific requirements of products being transferred
Internal and External Contacts
•Facilities and Engineering
•Health, Safety & Environment
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
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.