Associate Lab Supportt Engineer - Instrument Qualification GMP (Remote possible)

Submission for the position: Associate Lab Supportt Engineer - Instrument Qualification GMP (Remote possible) - (Job Number: 184267)

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

Our client is embarking on a multiyear global project, to standardize Quality Control (QC) instrument models and software to operate with the Windows10 PC platform. This is part of a wider programme, for the Network QC team, whose mission is to improve efficiency and business operations for the QC Laboratories (Client sites worldwide) by standardising instrumentation and Lab Data systems, through the execution of global projects. As a result, we are recruiting highly motivated individuals to support these global programmes.

In this position you will support multiple client QC sites, and hence will require approximately 20% travel and ability to work flexible hours to facilitate meetings across multiple time zones.

Responsibilities will include (but not limited to): Participate as part of a cross functional global project to qualify QC instruments and associated software. Support the implementations of a new standardized global qualification for QC instrumentation and associated software across five Client QC sites. Implement validation strategies for QC instrumentation and associated software, across ClientQC Laboratories. Create, execute and review network led QC instrument/software qualification documents in support of global QC projects such as; Network QC Instrumentation Standardization and Windows 10 upgrades. Deployment of Enterprise Empower3 FR5 to QC sites including requalification of associated QC instruments . Author qualification related deviations, identifying root causes and robust CAPAs. Author qualification related change controls and validation plans. Update Client procedures and documents to implement data integrity controls arising from instrument qualification programmes. Serve as liaison with lab-IT teams to harmonise QC instrument’s software configurations where applicable Ensure compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, lifecycle management, and computer system validation. Provide updates on qualification status, project timelines, and escalate challenges as required . Assist Network QC Equipment Lifecycle Lead in schedule development and workload management of project team

*LI-SW1

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

Our client is embarking on a multiyear global project, to standardize Quality Control (QC) instrument models and software to operate with the Windows10 PC platform. This is part of a wider programme, for the Network QC team, whose mission is to improve efficiency and business operations for the QC Laboratories (Client sites worldwide) by standardising instrumentation and Lab Data systems, through the execution of global projects. As a result, we are recruiting highly motivated individuals to support these global programmes.

In this position you will support multiple client QC sites, and hence will require approximately 20% travel and ability to work flexible hours to facilitate meetings across multiple time zones.

Responsibilities will include (but not limited to): Participate as part of a cross functional global project to qualify QC instruments and associated software. Support the implementations of a new standardized global qualification for QC instrumentation and associated software across five Client QC sites. Implement validation strategies for QC instrumentation and associated software, across ClientQC Laboratories. Create, execute and review network led QC instrument/software qualification documents in support of global QC projects such as; Network QC Instrumentation Standardization and Windows 10 upgrades. Deployment of Enterprise Empower3 FR5 to QC sites including requalification of associated QC instruments . Author qualification related deviations, identifying root causes and robust CAPAs. Author qualification related change controls and validation plans. Update Client procedures and documents to implement data integrity controls arising from instrument qualification programmes. Serve as liaison with lab-IT teams to harmonise QC instrument’s software configurations where applicable Ensure compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, lifecycle management, and computer system validation. Provide updates on qualification status, project timelines, and escalate challenges as required . Assist Network QC Equipment Lifecycle Lead in schedule development and workload management of project team

*LI-SW1

Qualifications:

Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5-8 years’) or equivalent combination of education, training, and experience.

Knowledge, Skills and Abilities: Minimum of 2 years’ experience in the pharmaceutical industry. It would be desirable to have at least 1 year experience in laboratory operational role. At least one year of experience in a GMP regulated lab is required. Demonstrated expertise in large projects within a complex high performance team, Desirable to have at least 1 year of experience in a role either (a) instrument qualification or (b) software validation, with detailed knowledge of regulatory requirements related to QC instruments and associated software Demonstrated ability to work independently as well as contribute to a team based collaborative environment and prioritise workload with minimum supervision as part of supporting multiple complex projects. Self-directed with a high degree of professional integrity, organization, and attention to detail. Strong interpersonal, oral and written communication skills are essential, including the ability to communicate at all levels with clarity and precision. Ability to work on multiple complex team projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations. Ability to work across timelines and be available to travel when required. De monstrated use of flexible thinking and growth mind-set is an advantage.

Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary and/or standing for typical working hours. Able to lift and move objects up to 25 pounds Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Qualifications:

Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5-8 years’) or equivalent combination of education, training, and experience.

Knowledge, Skills and Abilities: Minimum of 2 years’ experience in the pharmaceutical industry. It would be desirable to have at least 1 year experience in laboratory operational role. At least one year of experience in a GMP regulated lab is required. Demonstrated expertise in large projects within a complex high performance team, Desirable to have at least 1 year of experience in a role either (a) instrument qualification or (b) software validation, with detailed knowledge of regulatory requirements related to QC instruments and associated software Demonstrated ability to work independently as well as contribute to a team based collaborative environment and prioritise workload with minimum supervision as part of supporting multiple complex projects. Self-directed with a high degree of professional integrity, organization, and attention to detail. Strong interpersonal, oral and written communication skills are essential, including the ability to communicate at all levels with clarity and precision. Ability to work on multiple complex team projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations. Ability to work across timelines and be available to travel when required. De monstrated use of flexible thinking and growth mind-set is an advantage.

Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary and/or standing for typical working hours. Able to lift and move objects up to 25 pounds Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Submission for the position: Associate Lab Supportt Engineer - Instrument Qualification GMP (Remote possible) - (Job Number: 184267)