GSK
Associate Director, Process Engineering
GSK, Rockville, Maryland, us, 20849
Site Name:
USA - Maryland - Rockville Posted Date:
Aug 23 2024
The
Associate Director for the Process Engineering
function to support both Process Value Streams (VS) at the Rockville Biopharm site. This role will act as the point of contact for all process engineering support and will organize, prioritize, and direct the activities of the dedicated process engineers.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Collaborating with other functional groups (Production, Quality, MSAT, EHS, Supply Chain), proposing and driving value stream objectives, owning and reporting metrics, managing planned and unplanned work, and supporting investigations and RCAs.
Assign and prioritize all work requests and oversee project execution to ensure requirements are met, timelines are met, client’s needs are addressed, and projects aligns with GSK values and expectations.
Mentor and assist in skills development of the process engineers within the department
Demonstrates a proficient understanding of equipment, instrumentation, and materials of construction to specify, design, procure, construct, start-up, fully commission and troubleshoot equipment and systems including a general understand of other functions including automation and validation.
Lead in the evaluation, selection, and implementation of new equipment or modifications to existing systems with consideration to new processing technologies or strategies. This may include assessing an economic, environmental, quality, or productivity impact.
Coordinate the schedules and supervise the activities of contractors, vendors, and engineering teams including maintenance of equipment
Prepare or review operation, safety, and maintenance procedures to ensure accuracy and completeness
Own process systems as a subject matter expert to assist in regulatory audits and investigations
Provide support during off hours for complex issues that may arise to support ongoing VS operations
Lead investigations and discussions and recommend solutions with key customer groups in order to gain a consensus on the preventive and corrective actions
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
BS in Engineering or equivalent technical discipline
8+ years of experience as a process engineer in the biopharmaceutical industry
Experience working in a regulated GMP environment.
Experience working to standards required for regulatory compliance of aseptic processing facilities.
Project execution experience
Experience with delivering a project by delivering scope, cost and schedule.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Bachelor's degree in Chemical, Mechanical, Biomedical engineering
Demonstrated ability to participate as a leader or member on cross-functional and self-directed work teams
Exhibit the behaviours to interact with direct reports, peers, and site internal customers.
Engineering and process knowledge associated with various sterilization technologies, GXP utilities and associated pharmaceutical processes.
In-depth understanding and knowledge of cell culture and/or purification, including but not limited to bioreactor systems, centrifuges, CIP skids, chromatography system operation, column performance and UF skid operation.
#LI-GSK
#LI-Onsite
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
#J-18808-Ljbffr
USA - Maryland - Rockville Posted Date:
Aug 23 2024
The
Associate Director for the Process Engineering
function to support both Process Value Streams (VS) at the Rockville Biopharm site. This role will act as the point of contact for all process engineering support and will organize, prioritize, and direct the activities of the dedicated process engineers.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Collaborating with other functional groups (Production, Quality, MSAT, EHS, Supply Chain), proposing and driving value stream objectives, owning and reporting metrics, managing planned and unplanned work, and supporting investigations and RCAs.
Assign and prioritize all work requests and oversee project execution to ensure requirements are met, timelines are met, client’s needs are addressed, and projects aligns with GSK values and expectations.
Mentor and assist in skills development of the process engineers within the department
Demonstrates a proficient understanding of equipment, instrumentation, and materials of construction to specify, design, procure, construct, start-up, fully commission and troubleshoot equipment and systems including a general understand of other functions including automation and validation.
Lead in the evaluation, selection, and implementation of new equipment or modifications to existing systems with consideration to new processing technologies or strategies. This may include assessing an economic, environmental, quality, or productivity impact.
Coordinate the schedules and supervise the activities of contractors, vendors, and engineering teams including maintenance of equipment
Prepare or review operation, safety, and maintenance procedures to ensure accuracy and completeness
Own process systems as a subject matter expert to assist in regulatory audits and investigations
Provide support during off hours for complex issues that may arise to support ongoing VS operations
Lead investigations and discussions and recommend solutions with key customer groups in order to gain a consensus on the preventive and corrective actions
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
BS in Engineering or equivalent technical discipline
8+ years of experience as a process engineer in the biopharmaceutical industry
Experience working in a regulated GMP environment.
Experience working to standards required for regulatory compliance of aseptic processing facilities.
Project execution experience
Experience with delivering a project by delivering scope, cost and schedule.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Bachelor's degree in Chemical, Mechanical, Biomedical engineering
Demonstrated ability to participate as a leader or member on cross-functional and self-directed work teams
Exhibit the behaviours to interact with direct reports, peers, and site internal customers.
Engineering and process knowledge associated with various sterilization technologies, GXP utilities and associated pharmaceutical processes.
In-depth understanding and knowledge of cell culture and/or purification, including but not limited to bioreactor systems, centrifuges, CIP skids, chromatography system operation, column performance and UF skid operation.
#LI-GSK
#LI-Onsite
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
#J-18808-Ljbffr