Shire Systems Engineer II in Woodlands, Singapore
Primary Objectives of this Job
The core duties of Systems Engineer-Process Equipment role is to ensure process equipment and facilities are operating as intended to meet the requirements for biopharmaceutical manufacturing. Responsibilities of the Systems Engineer function include both tactical support of ongoing plant operations and strategic implementation of engineering projects to meet the changing needs of the business.
The role reports into Plant Engineering Lead/Supervisor at Singapore site and requires a skill-set that incorporates the following:
Experience with pharmaceutical/biopharmaceutical manufacturing operations in a cGMP environment.
Knowledge of unit operations associated with cell culture and downstream processing including: media make-up, bioreactors, depth filtration, sterile filtration, single-use technologies and chromatography skids & columns.
Strong knowledge of sanitary design aspects of biopharmaceutical manufacturing equipment including Clean in Place (CIP) and Steam in Place (SIP) concepts
Proficiency with troubleshooting of complex equipment and performing formal root cause analysis investigations
Demonstrated ability to lead technical projects from concept through implementation
The System Engineer – Process Equipment role includes traditional aspects of both plant and project engineering including the following responsibilities:
Act as system technical owner for upstream, downstream equipment and unit operations
Assist Validation Department with execution of qualification protocols including IQ, OQ, and PQ
Assist with technical transfer processes into the facility by employing Quality by Design (QbD) methodologies.
Author standard operating procedures (SOPs) for process equipment maintenance and preventive maintenance (PM) checklists
Ensure materials of construction of manufacturing equipment are appropriate to meet process requirements
Execution of commissioning and startup activities associated with equipment changes and new equipment installations including CIP/SIP commissioning
Identify and assist in procurement of spare parts required for process equipment maintenance activities
Manage construction activities associated with implementation of engineering projects
Own and implement projects to address Corrective Actions / Preventative Actions (CAPA) identified as part of deviation investigations, request from value stream stakeholders or GMP audits.
Participate as Site Engineering representative on cross functional support teams
Perform detailed technical designs for new equipment or changes to existing equipment through an understanding of user requirements and completion of design reviews with project stakeholders
Perform formal root cause analysis as part of deviation investigations
Provide on the floor troubleshooting support for manufacturing operations especially with regard to equipment issues
Raise and lead GMP change requests for implementation of changes to equipment and facilities
Review vendor turnover package documentation to ensure it meets all requirements
Support all phases of engineering project implementation to meet scope, schedule, budget, quality, and safety requirements. This work includes preparation of scope of work documents, cost estimates, and project schedules.
Timely closure of EHS and Quality event investigation and corrective & preventive action tasks
Responsibility to adhere to any applicable EHS requirements.
Commitment to a fair and respectful relationship to others and behavior in accordance with Shire’s Code of Conduct.
Any other duties as assigned by supervisor.
Education and Experience Requirements
A Bachelor of Science degree in Chemical, Mechanical Engineering or related engineering field is required.
3-5 years of experience in an engineering role supporting cGMP operations in a pharmaceutical/biopharmaceutical manufacturing plant is required.
Demonstrated mastery of technical drawings including PFDs, P&IDs, general arrangement drawings, and equipment design drawings is required.
3-5 Years of experience in the design and operation of biopharmaceutical manufacturing equipment and facilities.
Experience in the management and coordination of engineering and construction management consultants, equipment vendors and contractors.
Detailed knowledge of ASME Bioprocessing Equipment (BPE) guidelines.
Willing to be scheduled for call-outs during non-office hours to support manufacturing emergencies.
Key Skills and Competencies
The System Engineer – Process Equipment role includes regular interaction with both internal and global stakeholders and representatives from regulatory authorities. The position does not include direct supervision of Shire employees. However, supervision of contractors and trade workers is required during execution of projects.
The following additional qualifications are desirable and the candidate is expected to exhibit the following key core competencies:
Excellent Communication Skills
Ability to effectively communicate via writing and oral communication at all levels.
Express ideas effectively in individual and group situations (including non-verbal communication).
Ability to communicate to internal and external personnel and to communicate technical information to both technical and non-technical people.
Ability and willingness to express opinions and argue their basis.
Project Management Skills
Ability to handle multiple projects (5-10) simultaneously, keeping track of costs and schedule and ensuring compliance with quality and safety standards.
Use organizational skills to prioritize and resolve project issues.
A good understanding of design principles and standards within the biopharmaceutical facilities.
Ability to look at plant problems and come up with options for solutions.
Ability to understand and challenge design and execution concepts from outside vendors/engineers.
Ability to develop alternative courses of action that are based on logical assumptions, factual data and engineering principles.
The alternate actions take into consideration resources (financial and manpower), constraints and organizational priorities.
Provides solutions to a wide range of difficult problems; solutions are imaginative, thorough and practicable.
Gain approval for recommended solution and implement through proper channels.
Quality/Attention to Details
Ability to accomplish tasks through concern for all areas involved.
Demonstrating the proper level of detail for all aspects of the job; accurately checking processes, data and tasks; and maintaining attention over a period of time.
Ability to work effectively with internal and external teams or those outside formal line of authority (e.g. peers, senior managers) to accomplish goals.
Take actions that respect the needs and contributions of others; contributing to and accepting the consensus; subordinating own objectives to the objectives of the project team.
Represents the organization in providing solutions to difficult technical problems; frequent inter-organizational and global contacts.
Ability to establish a project execution plan that outlines the course of action for self and/or others to accomplish a specific goal.
Monitor the activities of consultants, vendors and contractors to ensure that resources are allocated properly in order to achieve project goals.
An understanding of how to work through company systems to establish goals.
Ability to make active attempts to influence events to meet the goals of the project or organization.
Given very general direction, independently determines and develops an approach to problem solving or project execution.
Reviews work in terms of meeting project and organizational objectives
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
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.