- Author and revise GMP documents and manufacturing records (e.g. Batch records, SOPs, change controls, etc.)
- Train staff in general manufacturing activities.
- Collaborate in the mitigation of any environmental, Health, and Safety (EHS) needs and risks.
- Identify and implement improvement initiatives to improve yield, reliability, and/or process robustness. This may require leading and implementing change controls.
- Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to the biopharmaceutical industry, as well as technical understanding/problem solving capability.
- Stay current with biopharmaceutical industry best practices and technologies.
- Responsible for organizing data and preparing appropriate documentation, including presentation materials, for assigned projects.
Lead any CAPA investigations:
- Lead problem solving and root-cause analysis sessions
- Interact with Quality, Engineering and Tech Service units
- Manage complex investigations using DMAIC tools
- Ensure effective implementation of corrective and preventive actions
- Multiple CCs Owner in Track-wise system (e.g. materials, process, equipment, IT systems, etc.)
- Project manage CCs implementation
- Ensure appropriate CC assessments are timely completed
- Coordinate CC implementation with all necessary teams
- Ensure staff is appropriately trained on changes
- Ensure documentation quality and regulatory compliance
- Independently develop schedules for manufacturing using system tools.
- Coordinate scheduling activities with support groups.
- Support work order reconciliation for your assigned area
- Revise existing or initiate new SOPs, Job aids, and Structured on the Job Training (SOJT) associated to material inventory, handling, and manufacturing scheduling process.
- Work with inventory coordinator to schedule, coordinate, and execute material transfers that include non-hazardous, hazardous and flammable chemicals to support manufacturing schedule adherence.
- Containment of issues as they arise on shift and effective escalation of issues as needed.
- Partner with supply chain planning to understand demand forecast and determine appropriate production plans.
- Manage reporting tools and metrics that support department and team goals.
- Contribute to a culture of safety first in compliance with Environmental, Health, and Safety (EHS). Understand and follow Job Hazard Analysis (JHA) packets.
- Train and explain process to others and ensure execution of processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply.
Key Skills, Abilities, and Competencies
- Strong problem-solving and analytical skills are required.
- Possess knowledge of core manufacturing principles and support systems.
- Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross functional teams and management on recommended course of action, with minimal assistance.
- Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
- Self-driven individual that requires minimal supervision.
- Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint).
- Must have a customer service and leadership attitude.
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, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda 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, a wholly-owned subsidiary of Takeda 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.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, 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.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, 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.