Manufacturing Specialist (Pharma/Biotech)

Responsibilities

• Perform technical writing and investigation of non-conformances in collaboration with Operations
• Identify and put in place appropriate corrective and preventative actions in conjunction with Operations team Change Management
• Structure common Operations Training modules and Train new hires on such modules
• Trends Key Performance Indicators and implement measures to streamline work processes and procedures GMP Document Authoring and Revision
• Electronic Batch Record Co-Authoring, Revision and improvement
• Participates / leads operations improvements and new product introduction projects
• Work with Quality systems (e.g. CAPA and change plans) and Operations
• Related System (LIMS, SAP, PI, Maximo, MS Office)
• Assist in regulatory inspections, detailing investigations and change plans.
• Work on continuous improvement projects
• About You:
• BS (or equivalent experience), with at least 2 to 5 years of relevant experience
• Strong working knowledge of GMP systems such as Trackwise, SAP, LIMS, MES systems are preferred
• Experience with cGMP documentation and record maintenance
• Experience with Regulatory inspections is required
• Strong ability to lead and drive cross functional teams
• Excellent attitude towards work, with strong drive to drive tasks to closure
• Agility, able to work under stress and cater to different priorities
• Good presentation and strong technical writing skills
• Good interpersonal and communication skills
• Duration: 12 months

Additional Information

Job Scope: To perform investigations, change plans or other functional support associated with cGMP manufacturing operations within the biologics production facility and work cross functionality.

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Company Intel

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