Total 5 job vacancies by Integrix Solutions Pte. Ltd.

Job Title: Service Operator

Department: Manufacturing Unit

Reporting To: Process Team Lead or Shift Lead

Job Purpose:

Execute assigned manufacturing tasks and activities according to production schedule incompliance with the relevant GMP, safety and environmental guidelines.

Perform routine operational support activities according to the manufacturing process and schedule and enable the timely production of product with the quality and quantity.

Major Accountabilities

Domain specific main activities

• Participation to the manufacturing support processes
• Execution of all assigned activities according to production schedule and in compliance with the valid GMP, work, operating, environmental and safety instructions and guidelines.
• Batch record review on time and without error (production part)
• Proper and timely cleaning, preparation and sterilization of the production equipment andproduction rooms
• Equipment parts management (punch, sieve etc.)
• Support on cleaning and changeover
• Work permit coordination where applicable
• Material movement in shop floor (including dispensing)
• Waste material management and pre-treatment of liquid waste streams) at shop floor
• Raw material ordering (filling daily tanks of solvents, Kanbans, packaging materials)
• Responsible for production area housekeeping (cleaning, tidiness, 5S...)
• Comply with and enforce health, safety and environment rules and guidelines (HSE)
• Apply and enforce the current GMP rules
• Sampling, aliquoting, distribution and performing of in-process controls
• Implementation of the delegated environmental monitoring for clean rooms and the delegated sampling of ultrapure water and pure steam if applicable
• Organization of immediate measures in the event of a fault, reporting abnormalities to the manager; experts and operational QA
• Ensure / monitor the proper functioning of the equipment in order to detect early signs of anomalies. Take appropriate action in the event of a malfunction.
• Documentation of the activities according to GMP regulations
• Manage the consumables supply necessary for the proper functioning of operations 
• Sort and eliminate waste related to production activities 
• Daily checks of manufacturing equipment, support devices and rooms 
• Clearly and precisely document the necessary remarks in the batch records
• Participate in the production schedule building-up (report delays, wrong activities duration...)and comply with it
• Commitment and participation to operational excellence and continuous improvement
• Proper handling of biological and chemical substances in the production plant
• Participation in all training relevant to the position, maintenance of the relevant training evidence
• Advancing and maintaining an HSE-compliant environment: reporting near misses

Non domain specific main activities

• Perform manufacturing related ERP transactions/activities
• Perform IPC related activities in LIMS or ERP system 
• Participate in investigations in the context of deviations, OOS, OOE, etc.

HSE and Quality

• Promote and improve the Safety and Quality cultures
• Apply in practical the upgrading, and the improvement of Safety and Quality on the shop floor
• Ensure overall inspection readiness for area of responsibility
• Supervision in their area, incident reporting and action follow-up at shop floor level
• Ensure the availability and proper use of Protective Equipment
• Comply with safety, cleanliness and tidiness rules (housekeeping, 5S)
• Detect and report potential accident, risks and propose solutions 
• Preparation and participation to internal HSE audits

Operational Excellence and continuous improvement

• Willingness to continuously improve and analyze weak points
• Suggest improvement actions (organization, process, safety, hygiene, etc.) at shop floor
• Manage / participate in continuous improvement projects in line with strategic objectives

Education:           Vocational qualification required in Chemical Engineering, Logistics, Computer science or equivalent experience

Languages:          Proficient in site local language

Experiences:        Experience(preferable) in chemistry / food / pharmaceuticals / biotech / aseptic manufacturing or projects

Role: Contract role

Operating shift: 12 hours of Rotating shift

Key Responsibilities

• Lead, Design and implement process automation systems and solutions to manage a batch pharmaceutical manufacturing environment
• Lead DeltaV System upgradation project, Determine the upgrade method (online vs. offline) based on production requirements, risk tolerance, and the necessity of controller switchovers.
• Hands on experience performing DCS (DeltaV upgrade)
• Manage software development projects from design to implementation for new automation/data collection systems and expansion to existing systems
• Support in system FAT and SAT
• Third party interfacing coordination, installation and validation of OSI Pi software
• Support troubleshooting and investigation of production process, equipment, systems and code/configuration related to quality or safety issues. Implement the relevant improvement solutions
• On-Call support for Biologics Manufacturing and API plants,
• Improvements/troubleshooting of existent Control Strategies,
• Project progressing according to plan and quality expectations
• Commissioning and qualification activities for new and upgraded equipment
• Mentor and train engineers in the automation team

Requirements

• Prerequisite: Min. 8 years experience in DeltaV System upgradation, Virtualisation, DeltaV Batch Software Design and Configuration.
• Degree in Chemical/Electrical Engineering, Computing or IT
• Excellent problem-solving ability and customer-focused
• Strong technical writing and documentation skills are required
• Must be proactive, have experience with high performance teams, strong interpersonal and project management skills
• Good teamwork and communication skills; ability to interact across functional teams at multiple levels within the organization
• Good skills in Windows operating system administration, programmable logic controllers, Visual Basic programming, databases and general programming would be added advantage
• Strong technical knowledge and experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems.
• Have strong trouble shooting capabilities. Be able to use engineering thinking and principles to tackle complex technical/process issues.
• Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices

Key Responsibilities

The incumbent will

• Lead, Design and implement process automation systems and solutions to manage a batch pharmaceutical manufacturing environment
• Manage software development projects from design to implementation for new automation/data collection systems and expansion to existing systems
• Support troubleshooting and investigation of production process, equipment, systems and code/configuration related to quality or safety issues. Implement the relevant improvement solutions
• On-Call support for Biologics Manufacturing and API plants,
• Configuration of batch recipes according to customer specifications,
• Improvements/troubleshooting of existent Control Strategies,
• Commissioning and qualification activities for new and upgraded equipment
• Mentor and train engineers in the automation team

Requirements

• Prerequisite: Min. 8 years experience in DeltaV Batch Software Design and Configuration
• Degree in Chemical/Electrical Engineering, Computing or IT
• Excellent problem-solving ability and customer-focused
• Strong technical writing and documentation skills are required
• Must be proactive, have experience with high performance teams, strong interpersonal and project management skills
• Good teamwork and communication skills; ability to interact across functional teams at multiple levels within the organization
• Good skills in Windows operating system administration, programmable logic controllers, Visual Basic programming, databases and general programming would be added advantage
• Strong technical knowledge and experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems as related to sterile products and medical devices
• Have strong trouble shooting capabilities. Be able to use engineering thinking and principles to tackle complex technical/process issues.
• Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices

Role : System Engineer (LabX)

We invite highly motivated individuals to join our team in providing support to our clients’ biomanufacturing facilities. In this role, you will be tasked with performing System engineer with qualification and System Administration for LabX software application at Client facility and ensuring strict adherence to pharmaceutical GMP and regulatory standards.

Job Description (JD):

1. Serve as the System Administrator for LabX software
2. Oversee and manage all method modifications within LabX
3. Lead the qualification of new laboratory equipment (e.g., pH and conductivity meters) integrated with LabX
4. Manage change control processes in compliance with quality standards
5. Maintain and manage CSV (Computer System Validation) documentation 

Timeline: 1 year contract

Scope of Work:

A) Performs routine and non-routine testings in the following areas with good observation of ALCOA+, cGMP, cGDP and cGLP requirements:

• Chemical testings for raw materials and utilities samples
• Chemical testings to support manufacturing processes, process validations, cleaning validations and reagent qualifications
• Timely support for projects and new product introduction (NPI) such as method verification and method validation / transfer (when required)
• Ensures right-first-time test executions and documentation, with schedule adherence.
• Performs peer review for verification of task and data.

B) Ensures training competencies are up-to-date and comply to global GSK training policies.

C) Performs equipment troubleshooting, calibrations, maintenance and verifications as assigned. Initiates repair work requests and liaise with vendors as necessary.

D) Identifies and reports issues (e.g. invalid results/OOS/atypical results/equipment failure) in QC to superintendent/manager in a timely manner. Participates in laboratory investigations (when required) and assist in timely closure of investigations and CAPAs.

E) Assists in document drafting and periodic review (e.g. SOPs, OJTs, WRAs, CRAs, QMCs, control charts)

F) Supports activities related to GPS (e.g. tiers, Gemba, DMAIC, 5S, standard work etc) for continuous improvement. Practises 5S and ensures good housekeeping of laboratory, work area and equipment. Also support lean activities and improvement projects with achievements.

G) Takes initiative to ensure good inventory of QC materials and reagents (e.g. purchased chemicals and prepared materials / glassware) to support testing activities; ensures no overstocking of inventory

H) Ensures inspection-readiness of the QC laboratories.

I) Adheres to all safety and security policies and practices. Ensures wastes are disposed appropriately and promptly.

J) Adhoc weekend, off-office hours support.

Timeline: 1 year contract