Cpl in partnership with our client Pfizer are looking to recruit a
NPI Operations Specialist
Department: Drug Substance Proteins
Position Reports to: NPI Operations Manager
The position is part of the New Product Introduction (NPI) operations team.
The purpose of this role is to represent the Operations function and provide operational and system support to the ongoing NPI requirements of the Drug Substance Operating Unit.
The NPI Operations Specialist is responsible for providing process, equipment and system support to the operating unit, ensuring that NPI Operations Readiness deliverables are completed as intended to support the manufacture of NPI related batches (e.g. water trial, engineering runs, Demo and Clinical Trial batches and Process Validation studies).
This project role focuses on tasks including but not limited to; detailed design/process mapping, closure analysis, risk assessment, SOP and Batch Record generation, training, standard work capability, 5S, Electronic Batch Record (PMX/AMPS) generation, process understanding in support of production scheduling model development and project management. Any changes introduced as part of project will require change control creation and implementation.
The role will also include supporting and resolving operational issues/ GMP investigations during NPI related batch execution.
The role also supports Ramp projects within Drug Substance and AMP’s implementation.
Successful timely completion of project objectives is a key aspect to this role.
Responsibilities:
• Participate in Operational Readiness Activities including Commissioning, Validation and Verification execution and trouble shoot technical issues.
• Responsible for right first-time creation of SOPs, paper and electronic batch records and assessments.
• Training of colleagues in new processes and equipment associated with NPI.
• Preparation of project schedules and completion of activities in line with project timelines.
• Raise, execute and manage QTS investigations and change controls relating to NPI.
• Sample plan review/approval and sample management during NPI campaigns.
• SME for operations providing expertise and insight to ensure that facility design enables safe and efficient operation. Collaborate with Product Changeover SME to maximize facility utilization.
• Specification and support of introduction of new materials and consumables for the Multi Product environment. Responsible for introducing Vendor Managed Inventory.
• Liaise with Tech Services, Engineering, EHS, Quality, Automation and external parties regarding aspects of operating a Multi-Product Facility.
• Participation in Factory Acceptance Testing for key equipment packages (Travel may be required).
• Lead/participate in Quality and Safety risk assessment activities.
• Update 5S plans to include new products requirements.
• Provide input into Bill of Materials.
• Align new products with IMEx principles and ensure smooth integration.
Qualifications:
Education/Experience:
• Diploma / Bachelors or equivalent experience.
• Familiarity of systems such as MCS, Orchestrate, MES, QTS, SAP, LIMS and PDOCs.
• 4+ years biopharmaceutical experience including knowledge and experience with relevant unit operations or laboratory operations.
• Experience of DS product specific equipment and materials would be beneficial.
• Experience writing technical documents such as SOPs, batch records and assessments.
• Experience or aptitude in managing projects.
• Excellent communications skills and problem-solving capabilities essential.
People/Values:
• Demonstrate the Pfizer values of Courage, Excellence, Equity and Joy.
• Adhere to all HR Policies as appropriate.
• Personal Development plans focus on the 70:20:10 guidelines.
• CI tools/- capability is a key building block for learning & development - Trained and M1 certified.
• Proactive engagement with key stakeholders.
• Recognition is actively practiced.
• Best practices developed and shared with other teams /sites.
• Best practices actively sought and copied.
• Proactive & effective communication within and different functional groups in the Operating Unit.
• Strong problem solver and demonstrate strong time management skills.
Working Patterns and Duration:
Day based Monday to Friday.
On call support may be required while NPI studies/batches are in progress.