equipment and validation engineer - Singapore - INTERNATIONAL WORKPLACE CONSULTING PTE. LTD.

Description

Our MNC client is hiring They are a global leader in the discovery, development and safe manufacture of new drug therapies.

There is a vacancy for EQUIPMENT AND VALIDATION ENGINEER.

Need to have experience in equipment qualification process from start to finish in the pharmaceutical field.

POSITION SUMMARY

This role's focus is on the planning, coordinating and resourcing routine equipment and/or facility maintenance activities and projects on-site. He/She ensures the qualification and validation of equipment, facilities, utilities, and processes are carried out in accordance with applicable GMP, GLP and/or ISO 17025 guidelines.

QUALIFICATIONS:

1. Education: Possesses at minimum, a degree in Engineering, Biomedical Sciences or any related field.
2. Experience:
   1. Minimum 1 year of relevant experience working in an ISO17025 / GLP / GMP environment is preferred.
   2. Understanding of IT is expected, related to installation of software, interface of hardware and software and basic administrative controls of Windows (Such as adding user groups) is preferred.
   3. Understand concepts and rationale, and execute System Commissioning, Qualification and Validation for systems as per requirements stated in ISPE GAMP 5 and USP <1058> document is preferential.
3. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
4. Others:
   1. Effective communication and supervisory skills
   2. Ability to organize and prioritize work to meet deadlines
   3. Ability to read, write, speak and understand English

QUALIFICATIONS:

1. Education: Possesses at minimum, a degree in Engineering, Biomedical Sciences or any related field.
2. Experience:
   1. Minimum 1 year of relevant experience working in an ISO17025 / GLP / GMP environment is preferred.
   2. Understanding of IT is expected, related to installation of software, interface of hardware and software and basic administrative controls of Windows (Such as adding user groups) is preferred.
   3. Understand concepts and rationale, and execute System Commissioning, Qualification and Validation for systems as per requirements stated in ISPE GAMP 5 and USP <1058> document is preferential.
3. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
4. Others:
   1. Effective communication and supervisory skills
   2. Ability to organize and prioritize work to meet deadlines
   3. Ability to read, write, speak and understand English

DUTIES AND RESPONSIBILITIES

1. Update or monitor the Master Schedule and Equipment Control Database for equipment-related activities to ensure that they are performed according to SOP.
2. Schedule, coordinate and supervise periodic maintenance, performed in-house or as arranged with external vendors for repair and calibration of equipment, and critical utilities at Charles River Singapore.
3. Manage facility maintenance activities and coordinate with external vendors for facility needs and requirements (For example, Pest Control programmes, biohazard and chemical waste management programmes, etc).
4. Perform matrices reporting such as safety incident report, submit safety matrices and monthly utilities usage for tracking and monitoring.
5. Assist in relevant license application / renewal from regulatory bodies pertaining to equipment use and laboratory operations.
6. Conducts periodic review, harmonisation of SOP for fitness-of-use, optimisation and compliance to appropriate regulations for equipment systems.
7. Attends monthly Environment, Health, Safety and Sustainability calls with manager.
8. Able to conduct training for various equipment systems being deployed in Charles River Singapore.
9. Maintains proper records and documentation of activities that are compliant with good documentation practices, continuous compliance ISO/IEC 17025, cGMP, PIC/S, ISPE Guidelines, WHO Technical Reports, Company global SOPs and other data integrity principles for all activities.
10. To work closely with all departments to ensure the operation of a validated environment according to existing QMS and/or other regulatory requirements.
11. Performs all functions as tasked with high degree of accuracy and strict adherence to company's quality requirements.
12. Reviews aspects/areas for improvement within your own duties/responsibilities and make recommendations to your line manager for your own or team improvements.
13. Adheres to Company Policies and Procedures.
14. Undertakes any other duty or responsibility, at the request of your manager that may be required within reason within the remit of your role.