Total 5 software engineer job vacancies in Engineering category in Singapore

Major Responsibilities

• Electronic Batch Records: Set up and manage electronic batch records for manufacturing processes.
• Process Improvement: Lead technical support and improvement initiatives to enhance ongoing manufacturing operations.
• Start-Up and Validation: Assist in the start-up, validation, and qualification of plant equipment and facilities.
• New Product Introduction: Support manufacturing activities during technology transfer, qualification, and validation batches for new products.
• Operational Efficiency: Contribute to achieving operational efficiency goals, including yield, product quality, and other key performance indicators (KPIs).
• Troubleshooting: Serve as a contact and consultant for process and equipment troubleshooting and investigations.
• Risk Assessment: Provide technical expertise for risk assessment activities.
• Cleaning and Changeover: Support process cleaning and changeover strategies.
• Documentation: Author and maintain technical reports, batch records, standard operating procedures (SOPs), investigations, and protocols, ensuring consistency and quality.

Skills and Competencies

• Technical Expertise: Strong knowledge of API manufacturing processes and equipment.
• Problem-Solving: Ability to quickly identify and resolve operational issues.
• Process Improvement: Experience in leading process improvement initiatives.
• Documentation: Proficient in authoring and maintaining technical documentation.
• Communication: Excellent communication skills for effective collaboration with cross-functional teams.
• Attention to Detail: Strong attention to detail to ensure accuracy and quality in all tasks.

Mission Description:

• Write, review, and approve validation SOPs and documentation.
• Maintain accurate validation documentation for computerized systems.
• Train other staff members on the correct use of computerized systems in line with protocols and regulations.
• Plan, write, implement, and review the computer systems validation (CSV) protocols in place.
• Compile and review validation data to ensure compliance with regulatory requirements.
• Ensure that all computer-based systems for GxP (good practice regulations and standards) are operating as intended.

Profile Requirements:

• Possess around 3-7 years of experience in computer systems validation (CSV) engineering.
• Strong coding skills and experience in configuring DeltaV.
• Knowledge of industry regulations and standards for computerized systems validation.
• Ability to write, review, and approve validation SOPs and documentation.
• Experience in training staff members on the correct use of computerized systems.
• Familiarity with GxP regulations and standards.

Job Description:

• Develop and implement quality control and quality assurance processes and procedures.
• Conduct regular inspections and audits to ensure compliance with industry standards and regulations.
• Identify and resolve quality issues through root cause analysis and corrective actions.
• Collaborate with cross-functional teams to improve product quality and reliability.
• Maintain detailed documentation of quality control activities and findings.
• Contribute to our mission of delivering high-quality products to our customers.

Requirements:

• Strong background in quality control and assurance.
• Experience in conducting inspections and audits.
• Proficiency in root cause analysis and corrective actions.
• Ability to collaborate effectively with cross-functional teams.
• Familiarity with industry standards and regulations.
• Excellent documentation skills.

Job Description:

• Develop and implement Computer System Validation (CSV) protocols and procedures in accordance with industry standards for DeltaV.
• Conduct risk assessments and validate computer systems, software, and automated processes to ensure compliance.
• Collaborate with cross-functional teams to gather requirements and define validation strategies.
• Create and execute validation plans, protocols, and reports, ensuring thorough documentation.

Requirements

• Bachelor’s degree in Engineering, Computer Science, or related field.
• Good understanding on deltaV, CSV protocol generation, documentation and coding
• Experience in CSV, specifically with DeltaV systems in the pharmaceutical or biotechnology industry.
• Strong understanding of DeltaV architecture, functionalities, and validation processes.
• Familiarity with electronic documentation systems and regulatory submission processes.

Job Description

• Develop and execute commissioning and qualification plans for systems and equipment, including IQ, OQ, and PQ protocols.
• Perform hands-on testing and validation; develop and implement validation strategies for processes, equipment, and software.
• Conduct risk assessments, manage validation documentation, and execute process, cleaning, and computer system validations.
• Ensure compliance with FDA, EMA, and cGMP regulations; stay updated on industry standards and prepare for regulatory audits.
• Maintain and review validation documentation; prepare and present validation reports and results.
• Identify and resolve validation-related issues, conduct root cause analysis, and implement corrective actions.
• Collaborate with engineering, QA, manufacturing, and IT teams; provide training on validation and compliance.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related field and 1-3 years of experience in CQV within pharmaceutical industry.
• Strong knowledge of GMP, FDA regulations, and industry standards; proficiency in validation, problem-solving, and communication skills.