- Singapore
Kerja Sepenuh Masa Lab Validation, Gaji tinggi SGD 6,000 di ANTER CONSULTING PTE. LTD. - Maukerja
Kongsi
Simpan
Lokasi Kerja
Penerangan Kerja
Tanggungjawab
Equipment Validation Engineer / Specialist
We are looking for an experienced Equipment Validation Engineer / Specialist to support the qualification and validation of environmental monitoring equipment within a regulated pharmaceutical/biopharmaceutical environment.
Key Responsibilities
Perform qualification and validation of environmental monitoring equipment, with a particular focus on
air samplers and particle counters
.
Develop, review, and execute equipment qualification protocols, including
IQ, OQ and PQ
, as applicable.
Ensure equipment qualification activities are performed in accordance with
GMP/cGMP requirements
, internal procedures, and applicable regulatory standards.
Prepare and maintain validation documentation, including protocols, reports, test scripts, deviations, and supporting records.
Investigate and resolve qualification or validation issues identified during protocol execution.
Collaborate with Quality, Engineering, Manufacturing, and other relevant stakeholders to ensure timely completion of validation activities.
Support equipment commissioning, calibration, maintenance, and change-control activities where required.
Requirements
Hands-on experience in
equipment validation and/or qualification
within a GMP-regulated pharmaceutical, biotechnology, or life sciences environment.
Demonstrated experience qualifying
environmental monitoring equipment
, particularly:
Air samplers / microbial air samplers
Particle counters / airborne particle counters
Good understanding of
IQ/OQ/PQ and equipment validation lifecycle principles
.
Familiarity with
GMP/cGMP requirements
and validation documentation.
Strong technical documentation, problem-solving, and stakeholder-management skills.
Degree or diploma in Engineering, Life Sciences, Pharmaceutical Sciences, or a related discipline is preferred.
At Anter Consulting, we offer bespoke strategic consultation. We promise unrivalled market knowledge and an extensive network of exceptional candidates.
We focus on delivering tailored solutions, through attentive consultancy services for your team, and finding the right people for your business.
We are looking for an experienced Equipment Validation Engineer / Specialist to support the qualification and validation of environmental monitoring equipment within a regulated pharmaceutical/biopharmaceutical environment.
Key Responsibilities
Perform qualification and validation of environmental monitoring equipment, with a particular focus on
air samplers and particle counters
.
Develop, review, and execute equipment qualification protocols, including
IQ, OQ and PQ
, as applicable.
Ensure equipment qualification activities are performed in accordance with
GMP/cGMP requirements
, internal procedures, and applicable regulatory standards.
Prepare and maintain validation documentation, including protocols, reports, test scripts, deviations, and supporting records.
Investigate and resolve qualification or validation issues identified during protocol execution.
Collaborate with Quality, Engineering, Manufacturing, and other relevant stakeholders to ensure timely completion of validation activities.
Support equipment commissioning, calibration, maintenance, and change-control activities where required.
Requirements
Hands-on experience in
equipment validation and/or qualification
within a GMP-regulated pharmaceutical, biotechnology, or life sciences environment.
Demonstrated experience qualifying
environmental monitoring equipment
, particularly:
Air samplers / microbial air samplers
Particle counters / airborne particle counters
Good understanding of
IQ/OQ/PQ and equipment validation lifecycle principles
.
Familiarity with
GMP/cGMP requirements
and validation documentation.
Strong technical documentation, problem-solving, and stakeholder-management skills.
Degree or diploma in Engineering, Life Sciences, Pharmaceutical Sciences, or a related discipline is preferred.
At Anter Consulting, we offer bespoke strategic consultation. We promise unrivalled market knowledge and an extensive network of exceptional candidates.
We focus on delivering tailored solutions, through attentive consultancy services for your team, and finding the right people for your business.
Peringatan Penting
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