East Jobs Cqv Engineer (pharma/biotech) Position at NUSANTARA PRIME CONSULTING PTE. LTD.
- Job vacancies posted on: 7 months ago
Are you looking for job vacancies? Our company, NUSANTARA PRIME CONSULTING PTE. LTD. is merrily inform you that we are hiring!
We need you to fill the position as CQV Engineer (Pharma/Biotech) for our office.
This position requires a contract working hours system which domiciled in East and its surroundings.
As a competitive company, we need these minimum criteria for candidates to be fulfilled. If you are a Not Specified and experienced in the field of Sciences & Biotechnology, a person who honesty and discipline, then you are highly awaited in our company.
The starting salary we can offer is in a range from SGD 2.000 - SGD 5.700, this salary range that we offer is negotiable can change at any time according to our HRD's decision depending on the capability of the candidate can offered for our company.
|Company||NUSANTARA PRIME CONSULTING PTE. LTD.|
|Position||Cqv Engineer (pharma/biotech)|
|Career Level||Not Specified|
|Type of Work||Contract|
|Minimum Salary||SGD 2.000|
|Maximum Salary||SGD 5.700|
The candidate is responsible to support equipment qualification, system qualification and cleaning validation. In this role, the engineer must ensure qualification activities are performed in accordance with the company’s policies and procedures, and regulatory requirements.
- Develop, review and/or approve validation lifecycle document and protocols/reports and deliverables in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion.
- Take lead and review project design documents (P&IDs, PFDs, URS etc.)
- Define user requirements and create SOPs or documentation related to the validation activities
- Manage qualification execution and lead validation deviation investigation encountered in qualification.
- Create and review validation lifecycle documents: User Requirement Specification, Functional Specification, Risk Assessments, Validation Protocols (IQ/OQ/PQ/CPV) and Reports, Study Protocols and Reports, Requirement Traceability Matrix, CFR Part 11 assessment and validation submission dossier
- Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification activities
- Participate in site Validation Maintenance Program.
- Write execution related deviations and change requests
- Support change implementation on site.
- Manage Change Control to update SOPs, Risk Assessment, Requirement Traceability Matrix and/or Automation System Life cycle documentation as needed
- Perform validation documentation and/ or support validation documentation in accordance to the division procedures
- Regular preview of pending activities to maintain validation status with validation lead, supervisor or manager
- Ensure validation execution meets compliance, validation standards and cGMP requirements
- Any other task as assigned by Supervisor/Manager
- Diploma/Degree in Engineering or Science Disciplines with 5 years experience in Pharmaceutical Industry
- Proven track record in Equipment Qualification for HVAC and Utilities Validation (IQ/OQ/PQ/CPV)
- In-depth knowledge on cGMP, GDP and ASTM E2500
- Proactive and self-motivated
- Demonstrated proficiency of written and verbal communication skills in English (including technical writing and presentations)
- Effective Project Management, leadership, communication and interpersonal skills
- To start asap till end of Jun 2023. 5 months
- Contract extension option depending on performance and business needs
Job Type: Contract
Contract length: 5 months
- Monday to Friday
- Equipment Qualification: 1 year (Preferred)
- HVAC and Utilities Validation (IQ/OQ/PQ/CPV): 1 year (Preferred)
- Get work experience
- Bonus for overtime
- Be taught first
- Good work environment
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