Senior Manufacturing Expert応募後で応募 求人ID R0036402 掲載日 06/15/2021 Location:Singapore, Singapore
Primary Objectives of this Job
With little supervision, the individual will support and coordinate routine GMP manufacturing life cycle and day to day operational activities associated with the products and process equipment in Takeda Singapore, including but not limited to Suite 1 Manufacturing, Suite 2 Manufacturing and Manufacturing Support areas. In addition, the individual will provide critical ad hoc support to continuous improvement, validation and CAPEX activities.
% of Time
Job Function and Description
The individual will support the EHS and cGMP compliance of day to day and tactical manufacturing activities and ensuring production activities are executed successfully.
Primary responsibilities include:
• Work hand-in-hand with the shift teams to ensure adherence to the production plan, resolve issues, as required
• Be considered to have more than one area of manufacturing expertise, for example, Upstream processing/Downstream processing/ Equipment Preparation/ Buffer Preparation and/or knowledge in key systems like EBM/XFP/CIP/SIP knowledge
• Act as subject matter expert during audits, explaining and walking through specific process operations or investigations, as applicable
• Carry out deviations investigations in the GEMS system, including product impact assessments and implement CAPAs
• Be a change control owner in the CCMS system, if applicable
• Maintain recipe configuration management documentation, if applicable
• Carry out material support activities including liaising with MLCM or vendors to address material issues, if applicable
• Develop and implement CAPAs arising from audits
• Informing management of events impacting production schedule
• Propose and review document revisions
• Carry out work in a safe manner, notifying management of safety issues and risks
The individual will manage equipment and support facility related projects by
• Assist in audit preparation as well as documentation related to audit responses, Adverse event notification review and Annual Product Reviews, as required
• Lead the transfer/implementation of new processes and commissioning & validation activities of new projects
• Lead complex investigations
• Lead continuous improvement
• Lead product change over activities
• Monitor and analyze processing parameters for atypical trends and improvement opportunities
• Act as a department training coordinator as required
Staff Technical Training and Development
• Meet and maintain training requirements on time
• Provide technical training for area personnel, as required
• Develop training material, as required
• Train and coach team members, as required
• Develop and maintain personal development plan
• Participate in site or global strategic initiatives, as required
• Provide feedback to peers to help staff development, as required
• Provide annual performance self-assessment on development plan
• Responsibility to adhere to any applicable EHS requirements.
• Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.
• Any other duties as assigned by supervisor.
Education and Experience Requirements
• Ph.D. in Chemical Engineering / Bioengineering / Chemical & Biomolecular Engineering / Pharmaceutical Engineering or M.Sc./M.Eng in Chemical Engineering / Bioengineering / Chemical & Biomolecular Engineering / Pharmaceutical Engineering with 0 - 2 years of relevant experience
• Degree in Chemical Engineering / Bioengineering / Chemical & Biomolecular Engineering / Pharmaceutical Engineering or related and possesses 2 - 4 years of relevant experience in the biotechnology or pharmaceutical industry
• Diploma in Applied Chemistry / Biomedical Sciences / Chemical Engineering / Food Science & Technology / Biologics & Process Technology / Chemical & Pharmaceutical Technology/ Food Science & Nutrition / Molecular Biotechnology / Biotechnology / Chemical & Biomolecular Engineering / Pharmacy Science or related and possess 4 - 6 years of relevant experience in the biotechnology or pharmaceutical industry
• Nitec in Biotechnology / Chemical Process Technology or related with 6 - 8 years of relevant experience in the biotechnology, pharmaceutical industry
• Excellent self-motivated team player with hands-on attitude and excellent communication skills
• Able to work on odd hours as required
Key Skills and Competencies
The individual should have good understanding of cGMP manufacturing aspects and had hands-on manufacturing experience.
• Excellent at technical writing as required for Electronic Batch Management (EBM), Batch Records (MBRs, MFRs) and Standard Operating Procedures (SOPs).
• Possess good communication and presentation skills
• Ideally be Green belt trained/certified and possess good understand of LEAN and Six Sigma concepts.
• Possess critical thinking skills
• Full awareness of current Good Manufacturing Practices (cGMP)
• Proficient documentation skills and computer skills including Microsoft Excel/Word/Powerpoint
• Good time management and team coordination skills
• Ability to work in a matrix environment
• Understanding of requirements from support functions and their capabilities
• Experience as a system user of business systems such as C3ME, XFP and Trackwise
• Will work holidays and overtime as required
• May be required to adjust work schedule to meet production demands
• Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes
• Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.
• May be required to stand for 6 hours in a production suite.
• May be required to climb ladders and work platforms.
• May be required to stoop or bend to check or trouble-shoot equipment
• May be required to work around chemicals (alcohols, acids & bases)