The Inspection and Packaging (I&P) Engineer supports all aspects of the visual inspection andpackaging program at CLE site in Xellia. The Engineer is a role model for quality, culture, andtechnique within the Inspection Area, and drive day to day activities in order to meet keyperformance objectives. The I&P Engineer assists in developing procedures and trainingmaterial to ensure proper operation and maintenance of inspection equipment, as well asensuring adherence to cGMP requirements. The individual in this position acts as a technicalresource for existing and future equipment and processes in the inspection and packaging area. Must have knowledge of validation cycle, including GAMP5.
The I&P Engineer has an integral role in supporting equipment start-up, commissioning andqualification, development of cGMP operating procedures, troubleshooting and continuousimprovement and supports ongoing inspection operations according to compliancerequirements, customer specifications and quality standards.
- Provide engineering technical support for problems and projects related to Inspection & Packaging operations, personnel, facility safety, and regulatory issues
- Provide leadership, oversight, coordination, administration, and design input formultiple projects, ensuring that all internal customers and company objectives are met in accordance with established company project management practices and procedures
- Develop (author), execute, and prepare reports for: specifications, protocols, test plans, and engineering studies. Ensure that packaging equipment is installed, commissioned, qualified, and maintained according to current pharmaceutical regulatory requirements, industry standards, government regulations, and company policies and procedures, as appropriate
- Ensure daily production is running optimally, in terms of defined KPIs related to output, quality, Environmental, Health and Safety (EHS). Lead troubleshooting and root cause analysis of critical processes or equipment issues.
- Partner with Quality to ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality.
- Support Inspection start-up, commissioning, and validation activities including IOQ and PPQ
- Perform operational testing and development of machine control equipment and visionsystems in a pharmaceutical manufacturing environment. Support troubleshooting ofcritical processes or equipment issues.
- Ability to draft site SOP's and cGMP's relative to the positions within Inspection &Packaging, and partner with Quality to ensure processes and products are in compliance with all local, state, and federal rules and regulations
- Organize and maintain test material for use in studies.
- The individual will primarily be working hands on with the equipment, executing test and collecting data. Expected to spend time on the shop floor, and be trained in the appropriate gowning.
- Ensure work activities are conducted in strict accordance with safety guidelines andprocessing standards, such as FDA's current Good Manufacturing Practices (cGMPs), SOPs and Annex1.
- Take a pro-active approach in making decisions with an awareness of the direct and indirect impact of all actions performed. Involve management when necessary.
- Improve manufacturing operations through optimizing process improvement, leading or participating in cost reduction efforts and technical improvement projects aimed atimproved equipment reliability, and maximizing utilization. Support a continuousimprovement culture and mind-set within the department.
- Work closely together with other departments to solve issues via investigationsdeviations, and CAPAs as they occur while ensuring timely release of products.
- Use root cause analysis to develop and implement permanent solutions to problems.
- Knowledge and understanding of regulatory requirements such as 21CFR part 210 and211, cGMP's, FDA, Annex1, OSHA and other regulatory agencies.
- Personnel engaged in the manufacture, processing, packing, or holding of a drugproduct shall wear clean clothing appropriate for the duties they perform. Protectiveapparel, such as head, face, hand, and arm coverings, shall be worn as necessary toprotect drug products from contamination.
- Bachelor Degree in Engineering or Physical Science (or other relevant education) is required (Mechanical Engineering Degree is preferred)
- Direct experience with machine vision equipment and systems highly desirable
- Be able to read and understand English andable to clearly write in English in order to sign and/or make annotations to cGmp documents using current Good Documentation Practices (cGDocP) is required.
- At least 2-4 years of related work experience in a regulated manufacturing environment setting preferred
- Experienced with; electro-mechanical equipment & principles, automated high-speedproduction, robotic, vision automation, or other relevant equipment required - preferably within a GMP environment
- Basic understanding of change management practices in a regulated, controlled environment is a plus
- Experienced with operation/testing of machine control equipment, machine vision systems and material handling equipment and/or packaging equipment is a plus
Physical Requirements of the role;
- Must be able to be gown qualified, and wear PPE (including respirator if required).
- This position will be frequently sitting, standing, and walking. In addition, repetitive use of hands, arm, and legs, as well as lifting and carrying up to 50 lbs.
- Any person that has shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions shall be excluded from direct contact with; drug products, in-process materials, components, containers, closures. This shall remain in effect until the condition is corrected or determined by competent medical personnel not to jeopardize the safety, efficacy, or quality of drug products.
- All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.
Xellia Pharmaceuticals is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections. Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia, the Middle East and North America. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,800 people.
With over 115 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs, comprising active pharmaceutical ingredients as well as injectable products. Continuing the Company's evolution, Xellia is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience and ease of use for healthcare professionals.
Together you can help us lead the fight against infections.
Further information about Xellia can be found at: www.xellia.com
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