Total 7 job vacancies by Orka Consulting Partners Pte. Ltd.

Key Responsibilities:

• Deliver CSV consulting projects to support implementation of computerized systems (e.g., DeltaV, Siemens PCS7, Rockwell PLCs) in the Life Sciences clients with compliance of GxP and other relevant regulatory standards.
• Deliver CSV consulting projects to support OS upgrade (e.g., Windows 11 upgrade) for laboratory and manufacturing equipment.
• Draft, review and maintain CSV documentation such as URS, FDS, Risk Assessment, Audit Trail Assessments, ERES assessments, Data Security Assessment, Validation Plans, IOPQ Protocols, RTM and any other lifecycle management documents.
• Provide expert consultation to ensure compliance with current regulatory requirements (e.g., GAMP5, 21 CFR Part 11, Annex 11).
• Support system configuration and computerised system (CS) activities such as backup and restore, access management, etc.
• Manage stakeholders from cross-functional teams (IT, Quality, Engineering, Operations) to plan and implement validation activities.
• Collaborate with other stakeholders including IT/OT, automation and quality teams to deliver validation projects on schedule.
• Draft, revise and review SOPs, forms and related operational and maintenance documents.

Requirements:

• Hold Bachelor’s degree in Life Sciences, Engineering or related field.
• Possess 2-4 years of experience in Computer System Validation (CSV), Automation, or related quality and compliance roles within a regulated environment (pharmaceutical, medical device, etc.)
• Familiar with CSV lifecycle management and automation systems validation.
• Had experience in leading a project from planning through execution and reporting.
• Able to manage stakeholders and deliverables within project timelines.
• Must be able to work independently and deliver results under minimal supervision.
• Understand computerised system regulatory requirements (e.g., 21 CFR Part 11, Annex 11) and industry best practice (e.g., ISPE GAMP5).
• Preferably with experience in change, incident and problem management.

Why Join Orka:

• Work that Matters: Support clients bringing innovative and life saving solutions to the population.
• Career Development: Build a consulting career in a professional consulting company with Life Sciences focus.
• Professional Environment: Work with similar professionals possessing Intelligent, Resourceful, Loyal and Teamwork characteristics.
• Impactful Learning and Mentoring: Develop yourself in an environment that heavily foster learning attitude and benefit from access to training materials, references, mentors and management with wide range of regulated industry experiences.

Key Responsibilities:

• Author, review, and approve Cleaning Risk strategy documents including assessments, protocols, and reports.
• Brief and guide cross functional teams on validation strategy and execution.
• Develop cleaning cycle development protocols, support execution, and optimize cleaning processes.
• Coordinate validation execution, sampling, and data review.
• Troubleshoot cleaning issues and support investigations and CAPA.
• Deliver other consulting projects in the process-related areas including but not limited to Technology Transfer, Sterilization-in-Place (SIP) PQ, Process Qualification and Process Validation.
• Draft other deliverables within full CQV cycle such as URS, risk assessment and data integrity assessment.

Requirements:

• Hold Bachelor’s degree in Life Sciences, Engineering or related field.
• Have worked for at least 3 years in pharmaceutical, medical device or related environment.
• Have at least supported Cleaning Validation (CV) activities as manufacturing or MSAT personnel.
• Preferably understand cleaning validation requirements and assessments including the concept of Health-Based Exposure Limit (HBEL), MACO, etc.
• Have working competency in the area of Fermentation, Centrifugation, chromatography and/or TFF/UFDF processes.
• Have good understanding of regulatory requirements and relevant industry best practice in Cleaning Validation (CV).
• Preferably with working knowledge of DeltaV including for logics such as handshakes and prompts

Why Join ORKA:

• Work that Matters: Support clients bringing innovative and life saving solutions to the population.
• Career Development: Build a consulting career in a professional consulting company with Life Sciences focus.
• Professional Environment: Work with similar professionals possessing Intelligence, Resourcefulness, Loyalty and Teamwork characteristics.
• Impactful Learning and Mentoring: Develop yourself in an environment that heavily foster learning attitude and benefit from access to training materials, references, mentors and management with wide range of regulated industry experiences. ORKA has several very experienced personnel in Cleaning Validation (CV) and other CQV disciplines.

Key Responsibilities:

• Design, configure and deploy MES in the pharmaceutical manufacturing plants.
• Integrate the MES system with other enterprise systems (e.g., ERP, PLM, LIMS) using appropriate integration methods.
• Develop and maintain electronic batch record, process instructions, recipes, workflows, electronic logbooks, etc.
• Develop and maintain reports, dashboards, and visualizations to provide insights into manufacturing performance.
• Provide technical support and training to end-users.
• Support qualification / validation activities including authoring and executing test scripts.
• Troubleshoot and resolve MES system issues, working closely with other stakeholders such as IT and manufacturing teams.
• Support project and system change management.
• Contribute to the continuous improvement of the MES system and related processes.
• Maintain updated system documentations.
• Identify gaps in system administration, management, quality and compliance, and drive operational improvement processes.

Requirements:

• Hold Bachelor’s degree in Life Sciences, Engineering or related field.
• Have worked for at least 2 years in the pharmaceutical industry. Fresh graduates with internship in supporting MES roll out or maintenance in pharmaceutical or medical device industry may apply for a Junior role.
• Have at least been a user of one Manufacturing Execution System (MES) (e.g., Syncade, PAS-X, OpCenter EX Pharma, POMSnet, PharmaSuite) and/or Data management or integration technologies (e.g., OSI PI, IP.21) or have authored recipes in the MES.
• Preferably with experience in system background including virtualization, software and hardware.
• Preferably with experience with system integration such as between MES and ERP, MES with DCS and / or MES and Historian.
• Preferably with working knowledge on database management.
• Preferably with understanding of manufacturing processes and equipment in the biopharmaceutical industry.
• Preferably having supported installation, administration and troubleshooting of computer systems and servers.
• Preferably with familiarity with cloud platforms.
• Preferably with reporting and data visualization tools.
• Understand computerised system requirements in the pharmaceutical industry (e.g., 21 CFR Part 11, Annex 11) and industry best practice (e.g., ISA 88, GAMP5).

Why Join ORKA:

• Work that Matters: Support clients bringing innovative and life saving solutions to the population.
• Career Development: Build a consulting career in a professional consulting company with Life Sciences focus. Exposure with mutliple MES solutions.
• Professional Environment: Work with similar professionals possessing Intelligent, Resourceful, Loyal and Teamwork characteristics.
• Impactful Learning and Mentoring: Develop yourself in an environment that heavily foster learning attitude and benefit from access to training materials, references, mentors and management with wide range of regulated industry experiences.

Key Responsibilities:

• Deliver consulting projects to support implementation of laboratory enterprise system (e.g., LES, LIMS) in the Life Sciences clients.
• Deliver consulting projects to support introduction, upgrade and maintenance of laboratory equipment with computerised system in the Life Sciences clients.
• Draft CQV and CSV deliverables such as URS, risk assessment, audit trail assessment, ERES assessment, IOPQ protocols, specifications and RTM.
• Execute CQ and CSV activities.
• Support equipment integration with other system such as network, manufacturing system and enterprise system.
• Support system configuration and CS activities such as backup and restore, access management, periodic review, etc.
• Draft, revise and review SOPs, forms and related operational and maintenance documents.

Requirements:

• Hold Bachelor’s degree in Life Sciences, Engineering or related field.
• Have worked at least 2 years in pharmaceutical, medical device or related environment.
• Preferably experience in configuring systems like LIMS (e.g., Labware), LES (e.g., Biovia LES), ELN, CDS (e.g., Empower, OpenLab), etc.
• Preferably experience in Windows Upgrade of computerised laboratory equipment.
• Understand computerised system regulatory requirements (e.g., 21 CFR Part 11, Annex 11) and industry best practice (e.g., ISPE GAMP5).
• Preferably with experience qualifying laboratory equipment with computerised system in pharmaceutical / medical device settings.
• Preferably with experience in change, incident and problem management.

Why Join ORKA:

• Work that Matters: Support clients bringing innovative and life saving solutions to the population.
• Career Development: Build a consulting career in a professional consulting company with Life Sciences focus.
• Professional Environment: Work with similar professionals possessing Intelligence, Resourcefulness, Loyalty and Teamwork characteristics.
• Impactful Learning and Mentoring: Develop yourself in an environment that heavily foster learning attitude and benefit from access to training materials, references, mentors and management with wide range of regulated industry experiences.

Short Job Description:

The CQ Engineer delivers commissioning and qualification services for equipment such as temperature controlled equipment / temperature controlled unit, warehouse, laboratory equipment (e.g., TOC analyzer, micro plate reader, MALDI-TOF, HPLC, osmometer), manufacturing support equipment (e.g., weighing balance, pH meter, weighing balance, CEDEX, ViCell, Solo VPE), HVAC, utilities (e.g., WFI, compressed air) and process equipment. The Engineer ensures that all systems are installed, tested, and qualified in compliance with cGMP, regulatory requirements, and project-specific standards.

Key Responsibilities:

• Deliver CQ services to support introduction, upgrade or decommissioning of manufacturing, manufacturing support and laboratory equipment in the Life Sciences (pharmaceutical / medical device) clients.
• Draft equipment qualification deliverables such as URS, risk assessment, data integrity related assessment, CQ (IQ/OQ) protocols, specifications and RTM.
• Review equipment vendor's IOQ documents.
• Execute and document qualification activities.
• Monitor and support equipment vendor in conducting equipment CQ, calibration and maintenance.
• Draft, revise and review SOPs, forms and related operational and maintenance documents.

Requirements:

• Hold Bachelor’s degree in Life Sciences, Engineering or related field.
• Have worked for at least 2 years in pharmaceutical, medical device or related environment.
• Have experience supporting or performing equipment CQ activities.
• Understand computerised system requirements in the pharmaceutical industry (e.g., 21 CFR Part 11, Annex 11).
• Preferably with experience in using VLMS like Kneat or Valgenesis.

Why Join ORKA:

• Work that Matters: Support clients bringing innovative and life saving solutions to the population.
• Career Development: Build a consulting career in a professional consulting company with Life Sciences focus.
• Professional Environment: Work with similar professionals possessing Intelligent, Resourceful, Loyal and Teamwork characteristics.
• Impactful Learning and Mentoring: Develop yourself in an environment that heavily foster learning attitude and benefit from access to training materials, references, mentors and management with wide range of regulated industry experiences.

Key Responsibilities:

• Deliver consulting projects in the process-related areas including but not limited to Technology Transfer, Cleaning Validation (CV), Sterilization-in-Place (SIP) PQ, Process Qualification, Shipping Validation and Process Validation.
• Draft CQV deliverables such as URS, risk assessment, data integrity related assessment and CV / SIP PQ / PQ / Shipping Validation / PV protocols.
• Execute CQV protocols and draft reports.
• Draft validation strategy for CV, SIP PQ, process qualification and process validation.
• Draft protocols for process comparability, resin lifecycle management, stability study and other process related protocols.
• Draft Technology Transfer documentations such as facility fit assessment, control strategy, etc.
• Support business and service development initiated by the management of Orka.

Requirements:

• Hold Bachelor’s degree in Life Sciences, Engineering or related field.
• Have worked for at least 3 years in pharmaceutical, medical device or related environment.
• Fresh graduates with internship in pharmaceutical or medical device industry and some relevant experience may apply for a Junior role.
• Have working experience in MSAT or pharmaceutical process related roles.
• Have working knowledge of DeltaV including for logics such as handshakes and prompts
• Have working competency in the area of Fermentation, Centrifugation, chromatography and/or TFF/UFDF processes.
• Have good understanding of regulatory requirements and relevant industry best practice.

Why Join Orka:

• Work that Matters: Support clients bringing innovative and life saving solutions to the population.
• Career Development: Build a consulting career in a professional consulting company with Life Sciences focus.
• Professional Environment: Work with similar professionals possessing Intelligent, Resourceful, Loyal and Teamwork characteristics.
• Impactful Learning and Mentoring: Develop yourself in an environment that heavily foster learning attitude and benefit from access to training materials, references, mentors and management with wide range of regulated industry experiences.

Key Responsibilities

• Review and approve electronic batch record (eBR), checklists and electronic logbook (elog) design on selected Manufacturing Execution System (MES).
• Advise on user oriented compliant eBR, checklist and elogbook design.
• Review and approve MES test scripts.
• Ensure that all GMP processes and operational / manufacturing personnel comply with current local and area specific procedures.
• Maintain a strong presence in the assigned operational areas, acting as the first point of contact for initial management of quality issues and be accountable for key quality decisions, including supporting initial impact assessment for deviations.
• Provide real-time guidance during GMP activities to proactively identify potential quality risks through active on-the-floor observation, enabling timely intervention to prevent deviations and defects.
• Authorise key processes such as product changeover activities, quality tag-outs of equipment and facilities, buffer and material release, and inspection lot usage decisions.
• Conduct spot-checks across production, warehouse and laboratory areas to ensure compliance with GMP standards, covering activities such as production, testing, cleaning and equipment maintenance.
• Perform real-time review of documentation and batch records to ensure content accuracy, appropriately handling of exceptions and adherence to Good Documentation Practices (GDP) aligned with ALCOA+ principles for data integrity, audit and traceability.
• Verify that facilities are being maintained in a good state in line with local housekeeping standards and escalate any deviation from the standards promptly ensuring associated remedial and corrective actions are implemented in a timely manner.

Qualifications

• Degree in Life Sciences (Chemistry, Biotechnology, or related field).
• Experience in GMP‑regulated biopharmaceutical manufacturing.
• Experience in Quality Operations (QO) and Manufacturing Quality Assurance (MQA) role for at least 1 year.
• Experience in reviewing executed eBR and understand review by exception methodology.
• At least has reviewed eBR / elog recipe revision.
• Preferably with experience in MES implementation project.
• Preferably with desire to pick up MES technical skills.
• Preferably having experience in sterile processing.
• Understanding of cGMP regulations and Pharmaceutical Quality System expectations.
• Effective collaboration skills across multiple functions and departments.
• Able to balance quality and business requirements.

What We Offer

• Career development: we will work with you and the client to give you a wider exposure to prepare for career consulting career.
• Teamwork: we deliver a service and not a manpower provider. You get a team to support you at your work and have fun together.
• Learning opportunities: we offer continuous learning through structured planning and development.
• Professional Environment: work with similar professionals possessing Intelligence, Resourcefulness, Loyalty and Teamwork.