Total 3 job vacancies by Anter Recruitment Pte. Ltd.

We are seeking a proactive, highly experienced, and detail-oriented Project Engineer to provide critical leadership and technical support . This senior role is responsible for ensuring the successful, compliant, and timely commissioning and qualification (C&Q) of complex process and utility systems, managing project progression, coordinating stakeholders, and driving tasks from design through handover.

Key Responsibilities

• Lead the development, review, and execution of commissioning protocols for complex bioprocess equipment (e.g., bioreactors, purification systems) and critical utility systems (e.g., purified water (PW), water for injection (WFI), clean steam, cleanroom HVAC).
• Mentor and provide technical guidance to the site project and commissioning team and external contractors, acting as a Subject Matter Expert (SME).
• Manage project progression for assigned packages, coordinating with design, procurement, construction, and internal stakeholders to ensure adherence to scope, budget, and schedule.
• Serve as the primary technical point of contact for commissioning and project execution, coordinating directly with Engineering, Validation (CSV/Process), Manufacturing Operations, and Quality Assurance stakeholders.
• Manage the full life-cycle of C&Q documentation, including the review and approval of Design Specifications, Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), and commissioning protocols, ensuring compliance with cGMP and regulatory requirements.
• Witness and sign-off on contractors’ testing and commissioning results, ensuring all activities strictly adhere to approved protocols, industry standards, and internal Quality requirements.
• Proactively conduct site inspections and system punch-listing to identify and resolve complex, project and commissioning-related issues before they impact the subsequent qualification (IQ/OQ/PQ) phases.
• Drive project administration, progress reporting, and documentation handover to the Validation and Operations teams, ensuring a successful transition.

Requirements & Skills

• 3+ years of progressive, relevant experience in project engineering, commissioning, qualification, or validation roles, with a strong focus on biopharmaceutical, pharmaceutical, or regulated advanced manufacturing environments.
• Proven track record of leading or significantly contributing to major capital projects involving cleanroom HVAC, utility systems, and/or complex bioprocess equipment.
• Bachelor’s degree or higher in Mechanical, Electrical, Chemical, Building Services Engineering, or a related discipline.
• In-depth knowledge of cGMP, GEP (Good Engineering Practice), and GAMP (Good Automated Manufacturing Practice) principles.
• Reliable, self-motivated, and a proven team leader with strong ownership and accountability.
• Exceptional communication, negotiation, and stakeholder management skills, comfortable challenging and influencing senior technical and operations personnel.
• Proficient in project management software, Microsoft Office Suite, and relevant data management tools.

We are looking for a Senior Automation Engineer who will be responsible for the design, installation, commissioning, and maintenance of site-wide control systems. This role ensures that all instrumentation and automation systems (DCS/PLC/SCADA) operate safely, efficiently, and in full compliance with global GMP and 21 CFR Part 11 regulations.

Key Responsibilities

• Lead the maintenance and troubleshooting of Emerson DeltaV DCS, Siemens S7, and Allen Bradley PLC systems.
• Manage the full lifecycle of E&I projects, from URS development and vendor selection to FAT, SAT, and final site handover.
• Execute Computerized System Validation (CSV) activities. Generate and review IQ/OQ/PQ protocols for process equipment and utilities (WFI, HVAC, Clean Steam).
• Review and update P&IDs, Loop Drawings, Instrument Data Sheets, and Cause & Effect matrices.
• Lead investigations into automation-related deviations and implement robust Corrective and Preventive Actions (CAPA).
• Collaborate with Manufacturing, Quality, and HSE teams to minimize downtime and ensure system integrity during "live" batch production.

Required Qualifications & Skills

• Bachelor’s Degree in Instrumentation, Control, or Electrical Engineering. A Master’s in Engineering Management is a significant plus.
• Minimum 8–10 years of experience in the GMP industry.
• Hands-on experience with Emerson DeltaV (Batch execution, hardware configuration).
• Proficiency in PLC programming (TIA Portal, RSLogix).
• Experience with high-speed packaging or containment systems (PTS, Isolators).
• Strong understanding of GMP, GAMP 5, and 21 CFR Part 11.

We are seeking a highly skilled CSV Engineer to lead the delivery of Process Control System (PCS) software and validation projects. This role focuses on the design, configuration, and computerized system validation (CSV) of DeltaV DCS and PLC systems to ensure compliance with GxP and 21 CFR Part 11 regulations.

Key Responsibilities (Mapped to SOL Duties):

• Software Design & Analysis: Analyze user requirements to design and develop software solutions for DeltaV (V15), including Control Modules, Equipment Modules, and ISA-88 Batch recipes.

• System Validation (CSV): Lead and execute Computerized System Validation (CSV) protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Software Installation & Operational Qualification (SIOQ).

• Documentation: Author and review critical technical software documentation: Functional Specifications (FS), Design Specifications (DS), and System Architecture diagrams.

• Digital Validation Tools: Utilize digital validation platforms (e.g., Kneat, ValGenesis) to manage paperless validation lifecycles and ensure data integrity.

• Infrastructure & Security: Configure and maintain virtualized environments (Hyper-V, VMware) and HCI (Hyper-Converged Infrastructure) for DCS software deployment, including domain controllers and cybersecurity hotfixes.

• Testing & Integration: Manage complex software interfaces between DCS, PLC, and Historian systems; perform loop checks and software shakedowns to ensure system interoperability.