Operations Person in Plant Drug Product External Manufacturing

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**Responsibilities**

This role is responsible for all activities related to the support of external manufacturing as defined in the Global Contract Manufacturing Standards. This role is a member of the joint process team (JPT) and has direct responsibility for oversight of the day-to-day operations at the CM.**

**This role will be a Person-in-Plant (PiP) in Dublin (Ireland) for Device Assembly and Packaging.**

**Key Objectives/Deliverables**:

- Define operational excellence roadmap and support CM in the implementation to improve safety, quality and productivity.
- Invest time on the shop floor to ensure practices match local procedures. Identify and promote operational best practices on the floor and set Lilly expectations.
- Establish and promote human error prevention program, tracking metrics and CM overall performance.
- Transfer operational knowledge to the CM to minimize recurrent deviations, ensuring flawless execution on the floor.
- Support On-Going CM Operations by providing operational oversight at the Joint process Team as Primary Loop support.
- The Operations PiP as a Person in Plant and as a member of the Joint Process Team should be the facilitator of the communication between the CM and the JPT, including:

- Become the primary contact person for the JPT, supporting the JPT Leader for escalation and issue management.
- Spend time on the floor to understand unit operation and the CM technology and monitoring line performance.
- Spend time on the floor while Lilly products are running on the manufacturing, assembling and packaging lines.
- Have a holistic understanding/knowledge of the product and process, including its associated equipment, facilities, computer systems and operations.
- Define, understand, and own the process control strategy, including key process parameters and critical quality attributes.
- Understanding product history and potential failure modes of the process.
- Contribute to identify and implement Continuous Improvement and Operational Excellence projects at the CM.
- Support JPT members to monitor the Technical Agenda identified at CM.
- Manage conflict and problem resolution.
- Assist the CMs in preparing for any audit from Lilly (GQAAC) or any external agency that impacts Lilly products.
- Translating process requirement and education to the Joint Process team members.
- The Operations PiP as a Person in Plant should provide support to the management of daily operations by:

- Support JPT members on deviations and complaints management facilitating the interface between Lilly and the CM.
- Assist JPT members in supporting the CM with periodic document preparation and presentation delivery.
- Support the root cause analysis process in case of deviations or complaints collaborating with CM SME (shopfloor presence).
- Ensuring planned changes and deviations are managed appropriately. Respond in a timely manner and accurately to requests for information.
- Proving troubleshooting support and maintaining awareness of issues, progressing their resolution and ensuring that JPT members and senior management are notified through approved escalation procedures.

**Relationship with CMO**:

- Identify training needs at the External Manufacturer and arrange/conduct training if necessary.
- Properly and timely inform the JPT Leader about quality issues, product delivery risks, etc. Identify root cause issues and recommend action plans to resolve them and avoid recurrence.

**Department Initiatives**:

- Maintain regular communication with management through effective participation in Routine governance meetings.
- As a team member, actively participate and contribute to the Joint Process Team objectives.
- Provide input in monthly reports and metrics through the JPT.
- Actively pursue opportunities for continuous improvement (both process and procedural).
- Model of Safety behaviors.

**Relationships**:

- All functions at the contract manufacturers from senior management to shop floor personnel.
- Lilly Affiliate personnel and senior Country and Area management (if required).
- Lilly Ops, Supply Chain, TS/MS, QA, Auditing groups, Laboratories at Lilly sites.
- All relevant functions at the Lilly IHL (if required).
- Senior Ops management, Lead team members, etc.

**Basic Qualifications**
- Education:

- Bachelor's Degree or equivalent work experience in Pharmacy, Chemistry, Engineering, or similarly related fields.
- Experience:

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