Sr Automation Engineer/ Quality Ops, Assurance Specialist/ Validation Engineer

Job Description

1. Automation Engineer

Job Responsibilities

• Provide automation support to Manufacturing Operations as part of the Process Automation group, focused on the Manufacturing Control System (MCS) to implement continuous improvement changes, support MAR (Make Assess Release) activities, and assist on capital projects.

Responsibilities include:
• Provide automation design and support for the MCS.
• Work with Manufacturing, Quality, and MSAT departments to implement corrective actions and continuous improvement changes, and support capital projects.
• Perform Quality discrepancy evaluations/assessments and provide support for Investigations.
• Perform troubleshooting and provide support for MCS system and software issues.
• Perform off-line and on-line coding, commissioning, and qualification.
• Review, revise, and approve automation design documents, and automation functional requirement documents.
• Assist with equipment testing and debug activities.
• Review and assess change records, risk assessments, and user requirements.
• Represent automation engineering on multidisciplinary and cross-functional project teams.
• Support and/or lead development and execution of automation change records (CRs and ACRs) and execute control qualification/commissioning test documentation.
• Perform cGMP reviews of executed Automation Work Plans and tests for completeness and accuracy.

2. Quality Operations/ Assuarance Specialist

• Provides guidance and support to innovations processes to meet GCP and regulatory requirements in the conduct of clinical trials.
• Assists in hosting Sponsor and regulatory inspections and conducts internal,
site, and vendor audits as assigned.
• Works closely and effectively with Development Innovations, Quality Management, Research Directors, clinical trial Sponsors, clinical study teams, site colleagues, and outside consultants.
• Providing guidance to research operations on the interpretation of regulatory requirements (standard/ policies/ procedures) related to quality assurance and GCP
• Performing quality functions and executing quality programs to support CRO processes
• Assisting in the preparation, hosting, and follow-up of Sponsor audits/ assessments and regulatory inspections
• Participating in the development and/ or review of standards, policies, procedures, and work instructions to support the quality management system and CRO processes
• Conducting internal, vendor, and site audits, including planning, executing, reporting, follow-up
• Providing guidance and support for deviations and corrective and preventive actions required by CRO activities
• Developing quality plans and/ or audit schedules as appropriate
• Identifying areas of deficiency and trends in quality and escalating to appropriate colleagues
• Developing, modifying, and utilizing tools to track and trend compliance issues
• Developing timelines to ensure timely and appropriate follow-up in areas of deficiency
• Maintaining records to support quality processes and audits
• Educating, training, and mentoring staff in quality improvement methods
• Attending training courses, conferences or association meetings to continue to gain knowledge and share information with other members of the group or company to increase awareness of industry trends
• Participating in divisional improvement efforts

3. Validation Engineer 

Responsibilities:
• Responsible for periodic revalidation of major process equipment in Clinical Pilot Plants and in Commercial Facilities.
• Conduct field cleaning validation testing including performance of visual inspection, and the collection of rinse water samples, swab samples, and/or extraction samples.
• Equipment will include: bioreactors, fixed tanks, transfer lines, chromatography skids, filtration skids, portable vessels, centrifuges, homogenizers, ultrasonic washers, glasswashers, lyophilizers, vial washers, chromatography columns, filter carts, and filter housings.
• Conduct thermal validation testing using thermocouple sensors and data collection instruments on equipment including GMP autoclaves, decon autoclaves, waste inactivation systems, dry heat ovens, lyo cabinets, bioreactors, holding tanks, portable tanks, transfer lines, and controlled temperature units (CTUs).
• All work includes protocol write-up, sampling plan generation, scheduling, Lock Out/ Tag Out, testing, report write-up, review, approval, and closeout.
• Lock Out/ Tag Out participation is to ensure zero energy of equipment and permit safely breaking into lines for testing.

Job Requirements

• Min 5 years experience working in a regulated environment

• A minimum of 2 years of experience in the design, implementation and/or support of instrumentation and control systems, preferably in the Bio-Pharmaceutical, Pharmaceutical, food or other batch processing industries would be at an advantage
• Experience with distributed control system, software development methodologies and automated system life cycle support in a regulated industry.
• Familiarity with Instrumentation, Systems, and Automation Society (ISA) Standards S88 and S95 as well as the International Society for Pharmaceutical Engineering (ISPE) Good Automated Manufacturing Practice (GAMP) Guide to the Validation of Automated Systems.
• Thorough understanding of cGMP’s particularly as they relate to the operation, validation and maintenance of computer-controlled systems.

• Quality or quality support experience in a regulated environment (GLP, cGMP, ISO)

• Working knowledge of process and cleaning validation
• Working knowledge of Computer System Validation
• Quality assurance or quality control experience in a cGMP pharmaceutical setting

• Sound working knowledge of processing equipment used to manufacture APIs

• Knowledge of cleanroom standards

Interested candidates please send a copy of your resume to leonleong@recruitexpress.com.sg 

Email Subject: Automation Engineer / Quality Specialist/ Validation Engineer

Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599