Process Engineer (Biochemical)

SUNNINGDALE TECH LTD.; Singapore; On-site; SGD 52,000 - 78,000; Full time

Job summary

Sunningdale Tech Ltd is a leading manufacturer of precision plastic components with global facilities and strong focus on Automotive/Aerospace, Healthcare, and Tooling. The position supports development, control and improvement of manufacturing processes and qualification activities to ensure quality and efficiency.

Responsibilities include process control, equipment qualification (IQ/OQ/PQ), CAPA, SOP maintenance, and cross-functional collaboration to meet production targets while upholding

Qualifications

• Diploma or Degree in Biotechnology, Biochemistry, Molecular Biology, Life Sciences, or related disciplines.
• 2-5 years of relevant experience in molecular biology or life sciences manufacturing.
• Hands-on experience with molecular biology techniques including PCR, qRT-PCR, nucleic acid extraction, and assay troubleshooting.
• Knowledge of GMP, ISO 13485, FDA regulations or similar quality systems is advantageous.
• Strong analytical, problem-solving and communication skills.

Responsibilities

• Support development, control and improvement of manufacturing processes and process parameters.
• Support and execute process qualification and validation, including IQ, OQ and PQ.
• Monitor process control, yield, throughput, downtime and abnormalities; take corrective action.
• Troubleshoot process and equipment issues and support root-cause analysis.
• Prepare SOPs, work instructions and validation records; provide training to production staff.
• Ensure equipment readiness and coordinate maintenance, calibration activities.
• Support new product introduction, process transfer and engineering changes.
• Collaborate with Quality, Maintenance, Planning and Purchasing to resolve issues.

Skills

Molecular biology

Analytical skills

Communication skills

Education

Biotechnology / Biochemistry / Molecular Biology degree

Tools

PCR

qRT-PCR

Nucleic acid extraction

Genotyping analysis

Job description

About Sunningdale

Sunningdale Tech Ltd is a leading manufacturer of precision plastic components. The Group provides one-stop, turnkey plastic solutions, with capabilities ranging from product & mould designs, mould fabrication, injection moulding, complementary finishings, through to the precision assembly of complete products.

Boasting a total factory space of more than 4 million sq feet, with more than 1,000 injection moulding machines and a tooling capacity of 2,000 moulds per year, Sunningdale Tech is focusing on serving four key business segments – Automotive/Aerospace, Consumer/IT, Healthcare and Tooling.

With manufacturing facilities across Singapore, Malaysia (Johor, Penang), China (Tianjin, Shanghai, Suzhou, Zhongshan, Guangzhou, and Chuzhou), Latvia (Riga), Mexico (Guadalajara), North America (Phoenix), India (Chennai), Thailand (Rayong), and Indonesia (Batam), Sunningdale Tech is strategically positioned to target and capture opportunities in diverse business sectors globally.

As an industry leader with deep engineering expertise and experience, Sunningdale Tech is driven to solve your challenges by applying our advanced capabilities & leading technology in ways that benefit you. We’re ready to provide solutions at every step of the process to reduce lead time and add value for customers, while maintaining our excellent quality. Beyond that, we build on our strong foundations to think out of the box and apply relevant new possibilities for your complex engineering problems. Customers can trust us to constantly solve challenges to meet their needs, and apply new ideas for better outcomes.

Responsibilities:

• Support development, control and improvement of manufacturing processes and process parameters.
• Support and execute process / equipment qualification and validation, including IQ, OQ and PQ, prior to mass production and following significant process changes.
• Monitor process control, yield, throughput, downtime and abnormalities; take or upscale corrective action.
• Troubleshoot process, equipment and in-process testing failures and support root-cause analysis.
• Support corrective and preventive actions (CAPA) for internal quality issues and customer complaints.
• Support continuous improvement in process capability, yield, cycle time, productivity, scrap and cost.
• Prepare and maintain standard operating procedures (SOPs), workinstructions, validation records and other technical documents.
• Provide process guidance and training to production personnel within assigned areas.
• Ensure equipment readiness, operates within approved conditions and coordinate maintenance, repair and calibration activities.
• Support new product introduction, process transfer, new equipment introduction and engineering / process changes.
• Work with Quality, Maintenance, Planning, Purchasing and other relevant functions to resolve manufacturing issues.
• Provide hands-on engineering support to daily production to meet quality, output and delivery targets.Monitor critical process consumables and materials required forproduction continuity.
• Support production coordination, including manpower / workstationallocation and resource prioritization when required.
• Ensure compliance with applicable quality, regulatory, EHS andinternal requirements.
• When delegated and appropriately qualified, coordinate dailyproduction activities and provide work direction to production personnel.
• Perform other duties reasonably assigned by the immediate superior.
• Take reasonable care of workplace health and safety; abide by all EHS policies and procedures; cooperate with Management and colleagues in EHS initiatives

Requirement:

• Diploma or Degree in Biotechnology, Biochemistry, Molecular Biology, Life Sciences, or related disciplines.
• Minimum 2-5 years of relevant experience in molecular biology, diagnostics, biotechnology, pharmaceutical, medical device, or life science manufacturing environment.
• Hands-on experience with molecular biology techniques including PCR, qRT-PCR, nucleic acid extraction, genotyping analysis, and assay troubleshooting.
• Knowledge of manufacturing process validation, equipment qualification (IQ/OQ/PQ), and process optimization.
• Familiarity with GMP, ISO 13485, FDA regulations, or related quality management systems will be an advantage.
• Experience in root cause analysis, CAPA, customer complaint investigation, and technical documentation.
• Strong analytical, problem-solving, and troubleshooting skills.
• Independent, results-oriented team player with strong interpersonal and communication skills.
• Good written and verbal communication skills.

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.

Only shortlisted candidates will be notified

Sunningdale Tech is an equal opportunity employer – we believe that a diverse and inclusive workforce will cultivate a vibrant, productive and innovative workplace where all employees are truly respected and valued.

All qualified applicants shall be considered for employment regardless of age, race, gender, gender identity, religion, marital status, medical condition, mental or physical disability, national origin, political and/or third party affiliation or veteran status. All offers of employment shall be conditioned upon successful completion of background checks, valid work passes and medical screenings, as applicable and/or mandated by law, and subject to the applicable local laws and regulations.