Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmic. Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.Summary
The position will be a team member of the Automation Engineering group. The Automation Engineering group at the Georgia manufacturing site is responsible to ensure that the manufacturing equipment/systems and Automation systems used in the manufacture, storage, testing, and distribution of Shire products are fit for purpose in accordance with Shire standards and industry regulatory requirements.
The Engineer is responsible for operational, maintenance and troubleshooting support for site automation systems including but not limited to manufacturing equipment such as: process tanks, Clean in Place (CIP), parts washers, chromatography, ultrafiltration, aseptic fill line equipment, packaging systems, water and chemical distribution systems, centrifuges, and filter presses. This position will provide support and ownership of the site automation systems which may include Emerson DeltaV, Allen Bradley PLC, OSI-PI plant historian, electronic batch reports, and others. The Engineer will implement area and system improvements through strict adherence to Standard Operating Procedures (SOPs) and cGMP's in a Pharmaceutical Manufacturing facility. The position will require participation in a rotating after-hour process control support function. Essential Duties and Responsibilities
- Provide hands-on technical support, diagnostics and troubleshooting functions to manufacturing operations and drive design improvements as applicable.
- Assess existing equipment and control systems in the various manufacturing area and determine the required changes to meet the design, reliability and requirements.
- Develop and review the automation of manufacturing process, support equipment and systems, design drawings and documents and equipment procurement packages
- Act as an area lead in one or more manufacturing process areas, overseeing all investigations and projects in that area.
- Engineer and manage process equipment/control systems reliability improvements, optimization, upgrades as well as implementation of new equipment control systems from concept to commissioning and validation.
- Work independently with minimal supervision to execute all facets of work.
- Design and implement changes to batch based control systems while adhering to validation and change control procedures.
- Support and/or lead continuous improvement, process optimization, reliability, expansion and upgrade projects.
- Update and develop User Requirement Specifications, Functional Specifications, Design Specifications, and Guidelines for new and existing equipment and control systems.
- Support and/or train technicians on control system functionality, troubleshooting and diagnostic techniques.
- Develop, revise and execute procedures for various control systems software configuration, hardware installation and back up and restoration.
- Develop and review submittals for technical content in accordance with project requirements
- Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability.
- Continuously stay current with assigned SOPs and keep an up to date training file ensuring compliance with all applicable Standatrd Operating Procedures.
- Ability to prioritize multiple tasks.
Education and/or Experience
- Must have excellent organizational, verbal and written communication skills; Able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance.
- Must have proficient computer skills and be experienced using MS Office software (Word, Excel and Powerpoint) and MS Project.
- Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
- Must be a self-starter, detail oriented and able to work independently with minimal supervision.
- Must possess experience in Distributed Control System implementation, especially DeltaV.
- Must have familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.
- Must display an understanding of theories/practices utilized by other disciplines outside of primary area of expertise.
- Must have basic knowledge in automation of pharmaceutical or food processing facilities, specifically fractionation and purification.
- Must possess the ability to manage commitments for self and team. Must display eagerness to learn and continuously improve.
- Has the ability to work on shift as needed for issue escalation support.
- Must possess basic knowledge in instrumentation, Foundation Fieldbus, DeviceNet and network designs
- Must have knowledge of system integration and data historians.
- B.S. degree required in an Engineering discipline with the preference being Chemical, Electrical or Computer, with 0-6 years
- Preferred engineering experience within the pharmaceutical, biotechnology or FDA regulated industry.