A well-established organization in the pharmaceutical and biotechnology industry is seeking a skilled Instrumentation Engineer to support critical operations at its Malaysia site. This contract role offers hands-on experience in a fast-paced, highly regulated manufacturing environment.
Role Overview:
We are looking for a technically proficient individual with strong knowledge of automation systems and instrumentation used in pharmaceutical or biotech manufacturing. The ideal candidate will be proactive, detail-oriented, and capable of supporting both maintenance and validation functions.
Key Responsibilities:
- Apply expert knowledge in packaging technologies, product serialization, and vision inspection systems such as Rockwell, Siemens, and Cognex.
- Utilize your understanding of automation systems like PLCs, DCS, SCADA, HMI, and variable frequency drives (VFDs).
- Prepare, review, and maintain documents aligned with Quality Management System (QMS) requirements.
- Conduct computer system validation and support qualification efforts including FAT, SAT, DQ, IQ, OQ, and PQ.
- Execute preventive maintenance of control systems and field instruments in accordance with the maintenance schedule.
- Monitor system alarms and report irregularities to the relevant stakeholders for timely resolution.
- Collaborate with mechanical teams to resolve instrumentation-related issues affecting production.
- Perform regular backups of plant systems and restore data when necessary.
- Maintain system access controls and enforce login-based security protocols for regulatory compliance.
- Address and communicate Environment, Health, and Safety (EHS) concerns promptly.
- Investigate safety incidents and support development of corrective and preventive actions.
- Contribute to continuous improvement initiatives and support any additional responsibilities assigned by engineering or management.
- Be flexible to work on rotational shifts and weekends as part of plant operations.
Ideal Candidate Profile:
- Background in pharmaceutical or biotech industries with a solid understanding of GMP and regulatory standards.
- Strong problem-solving, interpersonal, and analytical abilities.
- Experience in equipment and process validation, technical documentation, and maintenance procedures.
- A collaborative mindset with the ability to work effectively in cross-functional teams.
Interested applicants or referrals can be sent to shirley.k@rpint.com