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Supervisor-Engineer, Plasma Sorting Line

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.

The position will be a team member of the Supply Chain Organization focused on warehouse operations plasma sorting line. This position is responsible to ensure that the sorting equipment/systems and automation systems used in the sorting of plasma for Shire products are fit for purpose in accordance with Shire standards and industry regulatory requirements.

The Engineer/Line Supervisor is responsible for operating, maintenance and troubleshooting support for site automation systems including but not limited to the plasma sorting line and ancillary data bases and systems, line maintenance and cleaning. 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/Line Supervisor 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 ownership of multi-shift plasma sorting activities as yearly plans and LRP dictates.

While this position is target around the plasma sorting line, it is a part of the shared worker philosophy within the warehouse, where all supervision is cross trained and maybe called upon to assist and or run other areas within the warehouse on a short term basis to enable leveraging of our leadership team. Primarily the role will provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations. Responsible for supervising the day-to-day production compliance, training and auditing activities to meet customer requirements including deadlines and quality standards. Position will coordinate with the Plasma Operations team, Warehouse, and BioLife Quality teams to develop and adhere to process designs and improvements, scheduling, staffing, material management. This role will ensure that Biolife requirements are met while owning operations.

Essential Duties and Responsibilities

Create and maintain safe working environment

Provide hands-on technical support, diagnostics and troubleshooting functions to the Plasma Sorting Line operation and drive design improvements as applicable.

Act as Lead System Design (LSD), overseeing all investigations, projects and maintenance activities for the Sorting Line System.

Assess existing equipment and control systems and determine the required changes to meet the design, reliability and requirements.

Interview, hire, coach, motivate, develop and discipline staff. Conduct annual performance reviews for all direct reports. Assist in setting performance objectives and development plans. Monitor progress.

Review, approve, and manage documentation for batch and system records. Assist in release of product for further manufacturing operations. Assist in meeting product release time goals.

Emphasize training programs designed to enable staff to consistently execute all sorting processes with strict compliance to cGMPs and EHS regulations.

Develop and implement performance measurement and internal auditing programs in order to routinely evaluate operation efficiency and quality. Implement changes as needed based on assessments.

Perform/lead technical reviews, investigations and process improvement projects. Provide sorting line input into integration and validation of new equipment and processes.

Resolves technical, material and cGMP problems that may impact operational / project deadlines. Provide guidance and troubleshooting assistance as needed during a deviation in the process.

Represent the company during FDA inspections. Provide information as necessary to FDA that establishes credibility and demonstrates compliance with cGMPs

Provide a positive and equitable working environment emphasizing the Shire Shared Values: Respect, Responsiveness and Results

Design, implement and manage changes to control systems while adhering to validation and change control procedures.

Qualifications

Knowledge or programing experience on Rockwell Process Control applications: RSLogix5000, RSLinx Classic / Enterprise, FactoryTalk View SE HMI SCADA and FactoryTalk Transaction Manager.

Knowledge on database management system operation (Oracle / SQL Server), VBA programing and Crystal Reports.

Knowledge in field instrumentation including remote sensing technology (RFID), Visioning System, Ethernet/IP IO, Variable Frequency Drives and stepper motors.

Demonstrated interpersonal and leadership skills with ability to interface well with other departments, and lead effectively and efficiently in a team environment.

In-depth process knowledge of related manufacturing equipment and processes.

Ability to manage multiple priorities in a light manufacturing / sorting setting.

Ability to analyze and interpret scientific, and statistical data.

Strong professional writing skills and ability to prepare technical reports.

Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.

Strong assessment and troubleshooting skills.

Ability to respond to detailed inquiries, and present information to groups and senior management.

Will be required to supervise multiple teams / shifts.

Good computer skills.

Must have basic knowledge in automation of pharmaceutical or food processing facilities.

Education and/or experience

BS degree in Engineering field, Computer Science or Manufacturing with 2-5 years of experience

Physical Demands

Must be able to lift, push, pull and carry up to 50 lbs.

In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.

Working Environment

Must be able to work in controlled environment requiring special garments.

Will work in a cold environment

Must be able to work multiple shifts, including weekends.

May be required to work in a confined area.

Less than 5% travel.



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