As an Automation Engineer, you will design and implement automation systems and strategies, supporting building utilities and manufacturing equipment. You will collaborate with end users and stakeholders to enhance efficiency, develop standard operating procedures, and ensure quality through root cause analysis and corrective actions.
Duties and Responsibilities:
Lead the design of automation software and strategies, including process and supervisory control, electronic batch records, data collection, building management, and other auxiliary systems.
Support building utilities and manufacturing equipment focusing on building automation systems, HVAC, water systems, cell culture, and purification processing.
Interface with Manufacturing and other system end users and implement necessary changes to improve overall efficiency, including training.
Provide technical direction to engineering firms, equipment vendors, support contractors, and construction resources, including vendor acceptance testing and startup validation.
Develop standard operating procedures, including supporting recipe authoring and technical content development for digital systems while working with automation processes and systems.
Partner with Quality to assess deviations, determine root causes, and execute preventive and corrective actions.
Requirements and Qualifications:
Bachelor's degree in Engineering
5-10+ years of manufacturing experience in the biopharmaceutical or medical device industry
Extensive experience in leading product processing equipment support following FDA cGMP regulation requirements in a manufacturing setting
Extensive experience deploying and supporting digital systems for manufacturing support, including IT/OT interfaces and PLC programming
Able to work intermittent, on-call schedules as needed to support Manufacturing
Able to travel up to 10% of the role by air or road
Demonstrated experience collaborating with technical teams
Builds trustful and effective relationships with authenticity and humility
Confidence to lead through uncertainty in a rapidly changing environment
Able to contribute to a team where employees have a shared purpose and vision
Exceptional influencing, partnership, and collaboration skills across all levels
Excellent oral presentation and written communication skills
Physical requirements: must be able to put on specialized gowning, lift and manipulate items over 25 lbs, climb ladders, stand for multiple hours at a time
Desired Skills and Experience
Engineering, PLC programming, building automation, manufacturing equipment, HVAC, cell culture, purification processing, digital systems, IT/OT interfaces, FDA regulations, cGMP, biotech, pharmaceutical, medical device, travel
Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.
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