About PSC Biotech
Who are we
PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.
Take your Career to a new Level
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our clients expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.
An amazing opportunity has arisen for a Laboratory Systems Specialist. This role will support the Testing SDWT/Hub for testing of incoming raw materials in-process drug substance/drug product stability samples and environmental monitoring of the controlled manufacturing areas and utilities areas.
What you will do:
Bring energy knowledge innovation and leadership to carry out the following:
- The motivation to be an inspiring member of a high performing team.
- The desire to continuously learn improve and develop.
- Be the SME on data management systems for instrument control in the laboratories this includes but is not limited to GLIMS (Global Labware LIMS Platform) Laboratory Execution Systems (LES) Lonza MODA and Waters Empower.
- Work within an environment of right first time in everything that we do through a focus on principles of lean including simplification standard work visual management
- Build the Lab IT Systems to support Tech Transfer/Commercialisation of the biologics pipeline
- An understanding in analytical methodology (e.g. HPLC ELISA SDS-Page Glyco analytic Bio-Assays PCR capillary electrophoresis compendial assays).
- A working understanding of GMP ICH USP and global compendia regulations and guidances particularly as related to analytical method development and validation.
- The candidate will have strong problem solving and trouble shooting skills
Requirements
- Degree qualification in a Technical discipline.
- At least 2 years experience in laboratory systems Labware LIMS experience preferred.
- Previous experience with configuring building maintaining laboratory management systems such as LIMS/ MODA and /or Empower systems and interest in coding/ script.
- Ability to think logically and be proactive under pressure.
- Ability to work as part of a team and on own initiative in a constructive manner.
- Flexible and self-motivated.
Required Skills:
Bring energy knowledge innovation and leadership to carry out the following: Lead SAP master data build and data approval activities including hypercare sustainment materials build BOMs and Recipes. Participate daily on cross-functional teams collaboratively and actively to address compliance issues and achieve project milestones. Support implementation and training for site Quality Systems and site GMP readiness activities. Support creation maintenance and continuous improvement of Quality Management Systems (QMS) and associated documentation. Provide QA review and approval of Change Controls Deviations/CAPAs SOPS and related documentation for compliance to GMP and site requirements at the start-up facility. Support other QA colleagues as required. Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture. Support gathering of site metrics Ensure the escalation of risks to management in a timely manner.
About PSC Biotech Who are wePSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutio...
About PSC Biotech
Who are we
PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.
Take your Career to a new Level
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our clients expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.
An amazing opportunity has arisen for a Laboratory Systems Specialist. This role will support the Testing SDWT/Hub for testing of incoming raw materials in-process drug substance/drug product stability samples and environmental monitoring of the controlled manufacturing areas and utilities areas.
What you will do:
Bring energy knowledge innovation and leadership to carry out the following:
- The motivation to be an inspiring member of a high performing team.
- The desire to continuously learn improve and develop.
- Be the SME on data management systems for instrument control in the laboratories this includes but is not limited to GLIMS (Global Labware LIMS Platform) Laboratory Execution Systems (LES) Lonza MODA and Waters Empower.
- Work within an environment of right first time in everything that we do through a focus on principles of lean including simplification standard work visual management
- Build the Lab IT Systems to support Tech Transfer/Commercialisation of the biologics pipeline
- An understanding in analytical methodology (e.g. HPLC ELISA SDS-Page Glyco analytic Bio-Assays PCR capillary electrophoresis compendial assays).
- A working understanding of GMP ICH USP and global compendia regulations and guidances particularly as related to analytical method development and validation.
- The candidate will have strong problem solving and trouble shooting skills
Requirements
- Degree qualification in a Technical discipline.
- At least 2 years experience in laboratory systems Labware LIMS experience preferred.
- Previous experience with configuring building maintaining laboratory management systems such as LIMS/ MODA and /or Empower systems and interest in coding/ script.
- Ability to think logically and be proactive under pressure.
- Ability to work as part of a team and on own initiative in a constructive manner.
- Flexible and self-motivated.
Required Skills:
Bring energy knowledge innovation and leadership to carry out the following: Lead SAP master data build and data approval activities including hypercare sustainment materials build BOMs and Recipes. Participate daily on cross-functional teams collaboratively and actively to address compliance issues and achieve project milestones. Support implementation and training for site Quality Systems and site GMP readiness activities. Support creation maintenance and continuous improvement of Quality Management Systems (QMS) and associated documentation. Provide QA review and approval of Change Controls Deviations/CAPAs SOPS and related documentation for compliance to GMP and site requirements at the start-up facility. Support other QA colleagues as required. Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture. Support gathering of site metrics Ensure the escalation of risks to management in a timely manner.
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