Specialist, Engineer I
reputed company is a leading biopharmaceutical company focused on transforming patients' lives through science. The Specialist, Engineer I role involves supporting the production of personalized cell therapy products, providing manufacturing support, managing projects, and ensuring compliance with regulatory standards.
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 impact 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 arise during production
- Execute test plans, change controls, and other risk mitigation exercises as part of investigations (e.g. Root cause analysis and CAPAs)
- Stay reputed company with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities
- Support inspection readiness and actively support regulatory inspections and ensure safe and compliant cGMP operations
- Assist with revisions of the content of technical documentation (e.g. investigations, changes, SOPs and batch records)
- Interact 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 Quality 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
- Must have excellent organization skills and ability to handle multiple tasks
- Possess strong verbal/written communication skills and ability to influence at reputed company reputed company
- Ability to think strategically and to translate strategy into actions
- Ability to prioritize and reputed company clear direction to team members in a highly dynamic environment
- Hands on experience preferred with CAR T or biopharmaceutical manufacturing and Quality 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 Well-Being Account, BMS Living Life reputed company, and Employee Assistance Programs (EAP).
- Financial Well-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, legal support, and survivor support.
- Paid Time Off
- US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
- Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
- Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Company Overview
Company H1B Sponsorship