Validation/CQV Engineer (Singapore, Sydney, Melbourne)

Company Description

SeerPharma'smission is to advance Quality and GMP Best-Practices to Pharmaceutical and Medical Device companies in the Asia-Pacific region. We look to achieve this by offering training, consulting, software, and contract employment services addressing the Quality and GMP compliance issues companies face. SeerPharma hasassistedfirms involved with and/or conducting step(s) of manufacturing pharmaceuticals and medical devices for over 35 years. We have an outstanding history of successful work with a broad client base across the APAC region anda great teamof over 30 consultants and trainersassistingwith a vast cross-section of the major international standards, including PIC/S, FDA, EU, WHO, and ISO.

We have a friendly and inclusive culture and testimony to this is the length of time our staff stay at SeerPharma. It is also an excellent opportunity to increase the breadth and depth of yourknowledge,due to the variety of work we do.

A Contractor position has arisen for a self-motivated Validation/CQVEngineer to join the SeerPharmaEngineering Complianceteam. This role is pivotal as SeerPharma has secured several majorprojects andhas a pipeline of large facility projects in the Pharmaceuticaland Medical Deviceindustries.

The successful candidate will have a strongknowledgeofCleanroom design, includingHVAC designrequirementsfor cleanroomsin accordance withPIC/SGMPprinciples,plusdemonstratea willingness and initiative to learn from our current team of experts.

The role willreport to the Engineering Compliance Manager, andbeprimarilylocatedinSingapore,Melbourneor Sydneywith flexibility for some remote work.

For more background on our Engineering Compliance services, do visit:

https://www.seerpharma.com/services/gxp-consulting/engineering

Key Responsibilities:

• Plan,authorand executeGMPFacility QualificationdocumentsVMP, VPP, URS,DQ, IQ, OQ, PQ.
• PerformGMPFacility Design Reviews, and respondto technical queries
• Perform GMP Facility site inspections

Key Personal Attributes:

• Pragmatic and technical based approach
• Excellent technical writingskills
• Highly proficient in Microsoft Word
• You take pride in the quality of your written work
• Ability to work efficiently within a defined scope of work
• Ability tomulti-task andadjust to a change in priorities
• Ability to work within a team, as well as independently
• Excellent time management skills
• Excellent communication skills
• Open to travel and working on-site

Requirements:

• Engineering Tertiary Qualification
• 10+ years of relevant experience(or be able todemonstratean equivalent depth of experience)
• Proventrack recordinGMPFacility Qualification / CQVwithin the pharmaceutical, life science or medical deviceindustry.
• Strong understanding of PIC/S requirements for Facility design,operationand qualification
• Strong understanding of ISO 14644 Part 1,3 & 4 requirements.
• Practicalunderstandingof HVAC design for cleanrooms, and cleanroom design
• Experience in equipment qualification, cleaning validation and/or process validation would beadvantageous