General Purpose of Position:The Lead Automation Engineer is responsible for contributing to the development, oversight, implementation, and maintenance of the integrations between various enterprise software applications, such as ERP, SCADA, MES, LIMS, QMS, and CMMS systems. They will work closely with cross-functional teams to develop and execute integration strategies that enable seamless data flow and process automation across the organization in support of Aprecia's novel 3DP (3D Printing) pharmaceutical manufacturing platforms in a flexible, scalable, and secure IT/OT architecture.
Primary Duties and Responsibilities (Essential Functions):Duties/Responsibilities 1 Participate in the selection and implementation of applications across the full enterprise software architecture typical of a life sciences manufacturing & technology company. 2 Collaborate with engineering teammates, application owners, IT, and business stakeholders to understand integration requirements and align solutions with organizational goals. 3 Manage relationships with external vendors, including the selection, coordination, and oversight of contracts, timelines, services, and deliverables. 4 Utilize strong understanding of cGMP and regulatory statutes and guidelines to ensure a secure, robust, and compliant system of applications and data management. 5 Drive the development and implementation of integration solutions using enterprise integration patterns, middleware technologies, and API management tools. 6 Drive the development and maintenance integration workflows, data mappings, and transformation rules to ensure data consistency and integrity across connected systems. 7 Support the development and maintenance of digital dashboards for key stakeholders highlighting critical manufacturing and process data. 8 Troubleshoot and resolve integration-related issues, ensuring high availability and performance of the integrated systems. 9 Document integration design, configurations, and maintenance procedures to facilitate knowledge sharing and support ongoing operations. 10 Stay up to date with the latest integration technologies, best practices, and industry trends to continuously improve the organization's integration capabilities.
Reporting to this Position:
No direct reports
Travel:
Position may require periodic travel (0-10%)
Work Shift:
This position typically works days but occasional support may be needed at other times
Knowledge, Skills and Abilities: - Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
- Strong problem-solving and critical thinking skills, with the ability to identify and implement innovative solutions.
- Proven experience managing external vendors and overseeing complex projects.
- Working knowledge of pharmaceutical industry and cGMPs.
- Ability to learn and adapt to demands in a fast-paced work environment.
- Hands-on experience with 3D printing technologies preferred.
- Fluency in Microsoft Office Products (Word, PowerPoint, Excel, Visio).
Education and Experience: - B.S. degree in Computer Science, Information Systems, Electrical/Controls Engineering, or a related technical field required.
- 5-10 years of proven experience in enterprise application integration with a focus on SCADA, LIMS, MES, Data Historians/Warehousing, or other applications typical of a Life Sciences Manufacturing environment.
- Hands on experience with Ignition strongly preferred.
- Strong understanding of Cloud vs on-premise solutions and their implications on enterprise architecture.
- Hands-on experience with popular integration technologies, such as MQTT, SOAP, REST, XML, JSON, and message queuing.
- Familiarity with UNS data management and contextualization concepts.
- Familiarity with security protocols and practices, such as authentication, authorization, and data encryption.
Physical Demands and Work Environment: - Ability to stand for extended periods of time within the operations areas wearing required PPE (personal protection equipment)
- Ability to sit for extended periods of time to document and analyze testing results
- Good manual dexterity to operate computer, general office, and engineering equipment
- Able to clearly document specifications and other engineering needs/results
- Fine motor skills to manage more delicate engineering movements
- Good eyesight to read technical/instructional materials and drawings
- Occasional odd body positions (kneeling, bending, reaching) may be required while working with engineering equipment
- Ability to wear appropriate PPE as required for exposure to pharmaceutical operations (e.g. respirators, over-gowning, gloves, etc.)
GENERAL INFORMATION:The expectation for all employees is to support the company's mission, vision, culture and core values while adhering to all company policies.The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position.It is not intended to be an exhaustive list of all duties, responsibilities, and skills required.The position may require other duties as assigned and can be changed at any time by the company.
