**The Position**
This position will support operation team to ensure the operation performance achieve the target with the right procedure by providing technical expertise and execution on process validation, cleaning validation, change control, quality risk management, technical specification on material and component, and new product or line extension market, projects, continuous improvement activities, investigation of any atypical or deviation in the product, process or equipment, material, and component. Develop operational team by training as per requirement to support the technical operation activities.
**Duties/ Responsibilities**
- Primary activities include, but are not limited to:_
Operational management
- Execute process validation, cleaning validation, and equipment qualification that impact to quality of product
- Involve in tooling/engineering trials, installation, commissioning, and validation activities
- Execute change control process both internal and external site including change from supplier.
- Support and/or supervise operation team on investigation of any atypical or deviation result related to technical that happened in the product, process, equipment, material, or component.
- Participating in continuous improvement program and project or site objective as required.
- Support and execute transfer technology, new product, and extension market implementation.
- Maintain technical specification of material and component including creation, revision, or deletion.
- Support or supervise on troubleshoot/problem solving in manufacturing and packaging process as required.
Compliance/Quality/SHE
- Proactively support Permanent Inspection Readiness ensuring all documentation is made
- available during regulatory inspections and SMEs are available during inspections and support QMS Chapter if assigned.
- Implement all corrective actions are implemented in a timely fashion following regulatory inspections and internal audits.
- Support Safety to improve safety culture and ensure safety policies and guidelines are followed.
- Support Safety Investigations and corrective action implementation as requested.
- Responsible to keep abreast site safety & quality requirement and specific compliance policy and standards at daily work.
- Demonstrate quality leadership behavior, promotes a quality culture, and proactively supports cGMP compliance.
- Promote the site SHE culture, including but not limited to, the interdependency safety culture.
Documentation
- Prepare and execute technical documents as required for Qualification and Validation
- Raise deviations, completes the relevant documentation, and notify to related function.
- Coordinate and supervise of all deviations on process or product under his/her responsibilities.
- Maintain source documents.
Relationship Management
- Cultivate strong strategic interpersonal relations within and across IPTs, CoEs, COPs community and other colleagues at other sites.
- Demonstrate Organon Value and Culture Behavior
Knowledge maintenance and training
- Maintain individual technical competence and expertise.
- Provide technical advice as required and share best practices across IPTs, ES, COPs, CoEs or other colleagues at other sites.
- Liaise with all Engineers and with pertinent CoEs (i.e. Engineering), share best practices; collaborate with peers at other sites.
**Required Education, Experience, and Skills**:
- Educational background preferably in chemical engineering or pharmaceutical technology,
- Minimum 3 years experience in pharmaceutical company,
- Proven experience problem solving and troubleshooting in pharmaceutical manufacturing and packaging related process/product
- Proficient in both written and spoken English.
- Oral and written communication skills
- Rapidly acquires proficiency in emerging technologies and adeptly disseminates knowledge.
- Good level of knowledge of cGMP and regulatory inspections
- Results driven person who displaying high integrity and honesty.
- Has problem solving, decision-making, and teamwork skills.
- Passionate for continuous learning and capacity to drive change.
- Good knowledge of the key concepts, principles, methods, and tools related.
**Secondary Job Description**
**Who We Are**:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
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**Annualized Salary Range**
**Annualized Salary Range (Global)**
**Employee Status**:
Regular
**Relocation**:
No relocation
**VISA Sponsorship**: