The Automation Engineer's primary role is to support Manufacturing and Operations by providing technical support and troubleshooting day to day automation issues within a cGMP production environment. This position will play a key role in all stages of the engineering project and equipment lifecycle from conceptual design, detailed design, specification, implementation, commissioning, trouble- shooting, and continuous improvement of automation and instrumentation for pharmaceutical production and supporting utility systems. The Automation Engineer will coordinate with functional peers to define issues, develop and document solutions to complex problems, and communicate updates and performance back to peers and management.
- Strong organizational and teamwork skills required to be successful in a dynamic environment with changing priorities.
- Present and document control system project proposals, change management, system specifications and other technical documents, demonstrating strong written and verbal communication skills.
- Diagnose and solve moderate to complex automation problems to support 24/7 manufacturing activities.
- Ensure compliance with company policies, Standard Operating Procedures (SOPs) and cGMP requirements.
- Recommend new technologies and implement modern controls architectures in line with current trends in automation and instrumentation technology.
- Develop options assessments and recommend best course of actions based on data.
- Demonstrated project delivery, with ability to represent control system engineering design, construction and validation practices to regulatory authorities.
- Uses operational excellence and lean methodology to generate pragmatic, innovative and robust solutions.
- Apply traditional engineering project stages from origination through closure and rely on thorough options analysis to make data-driven recommendations.
- Establishes rapport, builds relationships that create networks with those individuals and stakeholder groups critical to short and long term goal attainment.
- Continuously aligns on expectations through on-going communication and open access to critical information.
- Proficiency with Microsoft products and the desire to learn additional software applications as required.
- Carry Company supplied mobile device for emergency on-call 24 hour support as required.
- Objectively analyze data and align expectations to bring definition to projects that have loosely defined objectives.
- Work across functions and disciplines to collect and analyze data to improve the compliance and efficiency of manufacturing activities.
- Identify and manage small projects involving multiple functions and disciplines within the organization.
- Good understanding of industry standards and practices related to controls software design and commissioning.
- 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. Develop knowledge of and understand regulatory requirements such as 21CFR part 210 and 211, cGMP's, FDA, OSHA and other regulatory agencies.
- Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.
- Bachelor's degree in Electrical Engineering, Engineering Sciences or, Associate Degree in Electrical Engineering with appropriate industrial controls experience.
- Minimum 3 years BMS, PLC, SCADA, Manufacturing Databases, instrumentation configuration, programming, and design in a cGMP environment.
- Experience with Allen Bradley PLC platforms as well as Siemens BMS systems, SCADA systems, PI Historian, iFix, iHistorian, Industrial Ethernet networks, ControlNet networks.
- Familiarity with batch and continuous processes within the Pharmaceutical Industry is preferred.
- Knowledge of GAMP 5 preferred
- Experience with S88 and ISA standards would be an advantage.
- Advanced GxP Data Acquisition and reporting.
Physical Requirements of the Role
Physical requirements include ability to lift at least 75 lbs and have excellent balance. Will be standing, bending, and walking frequently. Must be able to pass aseptic gowning qualification.
Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shallbe excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shallbe 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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