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Associate Lab Support Engineer - GMP

Pharmaceutical Product Development (PPD)

US-CA-Foster City-FSP Foster City CA

In labs and health care facilities worldwide -- HERE WE ARE

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by 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.

The Associate Lab Support Engineer provides support, leadership and ownership of the Laboratory’s calibration, preventive and corrective maintenance program. This includes all GMP and Research laboratory instrumentation and equipment using qualified service vendors and OEMs. Maintenance includes routine and emergency repair maintenance, performs calibration and qualification activities, and troubleshooting the issue associated with the CAL/PM/CM work order. Work is performed independently and documented in accordance with client’s standard operating procedures and established work order to meet all regulatory requirements. Prepares detailed system specifications based on user requirements for instrumentation for the purpose of coordinating demonstration units with vendors.

Duties include working with internal vendor service team (VST), and client’s laboratory leads and owners to schedule maintenance/repairs as needed. Detail the on-time performance using key metrics to drive further improvements on assigned projects. Plans scheduled GMP maintenance events on active instrumentation and equipment. Ensures scheduled calibrations/qualifications are performed on qualified vendors to include annual PM and OQ (Operational Qualification) and PQ (Performance Qualification). Prepares system documentation, including user requirements document, specification document, test plans and user manuals for instrumentation. Review qualification and PM/CAL documentation as it relates to the SOP. Informs management and lab lead on all potential issues that may delay instrument service timelines May perform remedial 6-month maintenance on active instrumentation and equipment and solve instrument problems and issues. Prepares and reviews SOPs pertaining to operation, maintenance and calibration of laboratory instrumentation and equipment. Oversees and manages installation of new laboratory instrumentation and equipment. Trains end users on existing instrumentation and equipment as required. Initiates deviations, out of tolerance (OOT) and laboratory events (LE) in accordance with procedures. Addresses audits on laboratory instruments and equipment. Directs personnel in the development and implementation of client’s departmental policies, procedures and programs. Provides scientific and technical consulting. Participates/coordinates multidisciplinary project teams to ensure projects progress smoothly. Attends team meetings to communicate progress of projects and issues to client management. Works with other scientists in the department to troubleshoot equipment. Responsible for ensuring service vendors performs installation, repair and preventive maintenance of GMP and Research laboratory Instrumentation and equipment in accordance with client SOPs. Initiates and implements plans to develop and improve areas in laboratory operation for greater efficiency, productivity and quality. Creates and implements novel approaches to new applications and method development to prove productivity and expand our business. Trains, mentors, and provides oversight to junior level staff as well as vendor engineers

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves.

Join PPD in our relentless pursuit of excellence - apply now!

In labs and health care facilities worldwide -- HERE WE ARE

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by 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.

The Associate Lab Support Engineer provides support, leadership and ownership of the Laboratory’s calibration, preventive and corrective maintenance program. This includes all GMP and Research laboratory instrumentation and equipment using qualified service vendors and OEMs. Maintenance includes routine and emergency repair maintenance, performs calibration and qualification activities, and troubleshooting the issue associated with the CAL/PM/CM work order. Work is performed independently and documented in accordance with client’s standard operating procedures and established work order to meet all regulatory requirements. Prepares detailed system specifications based on user requirements for instrumentation for the purpose of coordinating demonstration units with vendors.

Duties include working with internal vendor service team (VST), and client’s laboratory leads and owners to schedule maintenance/repairs as needed. Detail the on-time performance using key metrics to drive further improvements on assigned projects. Plans scheduled GMP maintenance events on active instrumentation and equipment. Ensures scheduled calibrations/qualifications are performed on qualified vendors to include annual PM and OQ (Operational Qualification) and PQ (Performance Qualification). Prepares system documentation, including user requirements document, specification document, test plans and user manuals for instrumentation. Review qualification and PM/CAL documentation as it relates to the SOP. Informs management and lab lead on all potential issues that may delay instrument service timelines May perform remedial 6-month maintenance on active instrumentation and equipment and solve instrument problems and issues. Prepares and reviews SOPs pertaining to operation, maintenance and calibration of laboratory instrumentation and equipment. Oversees and manages installation of new laboratory instrumentation and equipment. Trains end users on existing instrumentation and equipment as required. Initiates deviations, out of tolerance (OOT) and laboratory events (LE) in accordance with procedures. Addresses audits on laboratory instruments and equipment. Directs personnel in the development and implementation of client’s departmental policies, procedures and programs. Provides scientific and technical consulting. Participates/coordinates multidisciplinary project teams to ensure projects progress smoothly. Attends team meetings to communicate progress of projects and issues to client management. Works with other scientists in the department to troubleshoot equipment. Responsible for ensuring service vendors performs installation, repair and preventive maintenance of GMP and Research laboratory Instrumentation and equipment in accordance with client SOPs. Initiates and implements plans to develop and improve areas in laboratory operation for greater efficiency, productivity and quality. Creates and implements novel approaches to new applications and method development to prove productivity and expand our business. Trains, mentors, and provides oversight to junior level staff as well as vendor engineers

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves.

Join PPD in our relentless pursuit of excellence - apply now!

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

Knowledge, Skills and Abilities: Working knowledge and understanding of laboratory equipment and foundations of troubleshooting Knowledge of mass spectrometry, liquid chromatography, relational databases, and other analytical instrumentation operation Working knowledge with systems in use at PPD or within the CRO/Pharmaceutical industry Client focused approach with strong interpersonal skills Strong analytical and problem-solving skills Ability to communicate effective with vendors, clients and all levels of staff Attention to detail and ability to multi-task Ability to train others Ability to work in a collaborative team environment

Working Environment:

PPD values the health and well-being 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.

PPD Defining Principles:

We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

*LI-NW1

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

Knowledge, Skills and Abilities: Working knowledge and understanding of laboratory equipment and foundations of troubleshooting Knowledge of mass spectrometry, liquid chromatography, relational databases, and other analytical instrumentation operation Working knowledge with systems in use at PPD or within the CRO/Pharmaceutical industry Client focused approach with strong interpersonal skills Strong analytical and problem-solving skills Ability to communicate effective with vendors, clients and all levels of staff Attention to detail and ability to multi-task Ability to train others Ability to work in a collaborative team environment

Working Environment:

PPD values the health and well-being 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.

PPD Defining Principles:

We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

*LI-NW1

Job posted: 2021-04-13

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