Senior Consultant
Singapore, Singapore
Job Description
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Location: Singapore Job Type: Full-time
Job Summary: We are seeking a Senior Consultant with a mechanical background to provide CQV, HVAC, and design support to the pharmaceutical industry in Singapore. The successful candidate will be responsible for performing commissioning, qualification, and validation activities on mechanical equipment and systems used in pharmaceutical manufacturing facilities, as well as providing technical support for HVAC and design-related activities. In addition, the candidate will be required to provide administrative support to the project team.
Key Responsibilities:
- Conduct commissioning, qualification, and validation (CQV) activities on mechanical equipment and systems used in pharmaceutical manufacturing facilities in accordance with regulatory requirements and industry best practices.
- Develop, review, and execute validation protocols and reports for mechanical equipment and systems.
- Participate in the development of Standard Operating Procedures (SOPs) related to CQV activities.
- Conduct risk assessments to identify and evaluate potential hazards associated with mechanical equipment and systems used in pharmaceutical manufacturing.
- Provide technical support for HVAC and design-related activities, including the design, commissioning, and validation of HVAC systems and equipment.
- Collaborate with internal and external stakeholders to provide technical expertise and support for HVAC and design-related activities.
- Provide technical review and feedback on engineering drawings, equipment specifications, and design documentation.
- Perform administrative tasks related to CQV, HVAC, and design activities such as scheduling, tracking, and document management.
- Manage and lead small CQV, HVAC, and design projects as assigned, including coordinating and supervising project team members and ensuring project deadlines are met.
- Ensure compliance with regulatory requirements such as cGMP, FDA, and ICH guidelines.
- Keep up-to-date with industry trends and best practices related to CQV, HVAC, and design activities and provide recommendations for continuous improvement.
- Strong interpersonal, written and oral communication skills.
- Contributes and supports high-performance, cross-functional teams.
- Follows site specific work instructions, policies and procedures.
- Functions as a subject matter expert for manufacturing process.
- Analyzes and documents production data using standard scientific methods.
- Assist with troubleshooting throughout project scope as required.
- Works on multiple projects or tasks of moderate scope and complexity as a team member, requiring minimal supervision.
Qualifications:
- Bachelor\'s degree in Mechanical Engineering, Life Sciences or related field.
- At least 5 years of experience in the pharmaceutical industry with a focus on validation.
- Strong knowledge of regulatory requirements such as cGMP, FDA, and ICH guidelines.
- Experience with validation of equipment, systems, and processes in a pharmaceutical manufacturing environment.
- Familiarity with statistical analysis tools and techniques for data analysis, such as Design of Experiments (DoE) and Statistical Process Control (SPC).
- Excellent communication and interpersonal skills, including the ability to communicate technical information to non-technical stakeholders.
- Proficient in Microsoft Office Suite and experience with electronic document management systems.
- Self-starter with the ability to work independently and in a team environment.
- Strong project management and leadership skills, including the ability to prioritize tasks and manage multiple projects simultaneously.
- Fluent in English. Mandarin is advantageous (may required to communicate with chinese clients)
- Able to work legally in Singapore.
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Job Detail
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Job IdJD1301556
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationSingapore, Singapore
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EducationNot mentioned