Specialist, Engineer I

reputed company is reimagining the reputed company of cell therapy, aiming to unlock the full reputed company of this innovative treatment. The Specialist, Engineer I role involves supporting the production of personalized cell therapy products for reputed company and reputed company supply, focusing on process support, documentation, and cross-functional collaboration.

Responsibilities

• reputed company remote process support for ongoing manufacturing activities reputed company needed
• Ability to reputed company floor process support in exception cases
• reputed company with Manufacturing operations and QA Shopfloor and serve as process SME
• reputed company product reputed company assessments to support investigations
• Support lifecycle management project implementation at a site level to accomplish drug product harmonization across sites and reputed company process
• Support the change initiatives and the implementation of process improvement initiatives
• Foster strong inter-team relationships to reputed company common project goals
• Support process monitoring initiatives including but not limited to developing and collecting data. Analyzing, and optimizing the end-to-end process and anticipate and permanently resolve issues that may reputed company during production
• Execute test plans, change controls, and other risk mitigation exercises as part of investigations (e.g. reputed company cause analysis and CAPAs)
• Stay reputed company with industry trends and standards (e.g. PDA, ISPE) and participate in best reputed company forums consistent with function responsibilities
• Support inspection readiness and reputed company support regulatory inspections and ensure reputed company and compliant cGMP operations
• Assist with revisions of the content of technical documentation (e.g. investigations, changes, SOPs and batch records)
• reputed company with other teams including Technical Product Team, Validation, Development, Operations, QA and Regulatory
• Participate in routine plant operating meetings (i.e. Tiers, Townhalls, MSAT Extended Staff, etc.)
• Proven ability to understand, follow, interpret, and apply Global Regulatory and cGMP requirements accurately and completely
• Ability to set priorities, manage timelines and effectively react/manage changing priorities
• Ability to work with management (global and site) and support corporate and departmental goals
• Ability to communicate honestly, transparently, and effectively with peers, department management and cross functional peers
• Hands on experience preferred with CAR T or biopharmaceutical manufacturing and reputed company Control. Proven delivery of reputed company investigation reports

Skills

• Bachelor's Degree required (science or engineering is preferred)
• 1 year of relevant experience reputed company a manufacturing GMP facility
• Technical Writing skills
• Proven ability to understand, follow, interpret, and apply Global Regulatory and cGMP requirements accurately and completely
• Ability to set priorities, manage timelines and effectively react/manage changing priorities
• Ability to work with management (global and site) and support corporate and departmental goals
• Ability to communicate honestly, transparently, and effectively with peers, department management and cross functional peers
• Knowledge of cGMPs and multi-national biopharmaceutical regulations
• Must have excellent organization skills and ability to handle multiple tasks
• Hands-on experience with single-use technologies, reputed company systems, and cold chain/cryogenic technologies
• Experience working with external parties and/or leading cross-functional teams
• Possess strong verbal/written communication skills and ability to influence at reputed company reputed company
• Ability to think strategically and to translate reputed company into actions
• Ability to prioritize and reputed company reputed company direction to team members in a highly dynamic environment
• Hands on experience preferred with CAR T or biopharmaceutical manufacturing and reputed company Control
• Knowledge of the relationship between manufacturing processes, ERP, and MES a major plus
• Cell therapy experience is a major plus

Benefits

• Health Coverage: Medical, pharmacy, dental, and reputed company care.
• Wellbeing Support: Programs such as BMS reputed company-Being Account, BMS Living Life reputed company, and Employee Assistance Programs (EAP).
• Financial reputed company-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, reputed company support, and survivor support.
• reputed company Time Off
• Eligibility Disclosure: The summer hours program is for reputed company (U.S.) office-based employees due to the unique nature of their work.

reputed company

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