Job Description
Site Name: UK - Hertfordshire - Ware RD
Posted Date: May
Principal Device Engineer
Biopharm Process Development is a highly experienced Chemistry, Manufacturing and Controls (CMC) organisation accountable for delivering robust, cost effective and competitive products, and manufacturing processes spanning the full lifecycle of asset development from Discovery through commercialisation. These activities are delivered through state-of-the-art internal facilities as well as strategic external partners. Collectively, the team is accountable for CMC activities encompassing cell line development, cell culture/ microbial fermentation, purification development, and drug product/ device development. We also pioneer innovative technologies to improve robustness, reduce cost of goods, and improve the patient experience.
Within Biopharm Process Development sits GSK's Device Engineering team; an in-house device development group charged with the delivery of robust, patient-centric devices that enable the effective delivery of novel pharmaceuticals.
Job Purpose:
We have an exciting opportunity for a Principal Device Engineer to join a multi-skilled team of Engineers and Scientists who work across all stages of the product and process development lifecycle, from concept design and selection through to the regulatory submission and commercial supply.
You will be responsible for technical leadership of device development activities to support industrialisation of drug delivery platforms. You will be familiar with Quality by Design principles and developing programmes of work to build understanding of device designs and mechanisms.You should have awareness of in-silico modelling approaches which support device and mechanism understanding.
Key Responsibilities:
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Basic Qualifications/Experience:
Preferred Qualifications:
Why GSK?
GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. This special purpose - along with our goal of being one of the world's most innovative, best performing and trusted healthcare companies - helps us attract some of the best and brightest minds in the world.
We take pride in providing access to all and continually focus on our opportunity and obligation to do more to improve inclusion and diversity: for our people inside GSK; in the way we do business; and in the communities where we operate.
We want our company to be a place where diversity of people and thought is valued everywhere and where we're all able to be ourselves and feel a sense of belonging. An inclusive organization where we all feel valued, engaged and supported, knowing that our work makes an important contribution to our mission.Reinforced by our clear values and expectations , it is part of our DNA. Together we achieve extraordinary things for our patients and consumers, who rely on us each and every day
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on , or send an email
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
Posted Date: May
Principal Device Engineer
Biopharm Process Development is a highly experienced Chemistry, Manufacturing and Controls (CMC) organisation accountable for delivering robust, cost effective and competitive products, and manufacturing processes spanning the full lifecycle of asset development from Discovery through commercialisation. These activities are delivered through state-of-the-art internal facilities as well as strategic external partners. Collectively, the team is accountable for CMC activities encompassing cell line development, cell culture/ microbial fermentation, purification development, and drug product/ device development. We also pioneer innovative technologies to improve robustness, reduce cost of goods, and improve the patient experience.
Within Biopharm Process Development sits GSK's Device Engineering team; an in-house device development group charged with the delivery of robust, patient-centric devices that enable the effective delivery of novel pharmaceuticals.
Job Purpose:
We have an exciting opportunity for a Principal Device Engineer to join a multi-skilled team of Engineers and Scientists who work across all stages of the product and process development lifecycle, from concept design and selection through to the regulatory submission and commercial supply.
You will be responsible for technical leadership of device development activities to support industrialisation of drug delivery platforms. You will be familiar with Quality by Design principles and developing programmes of work to build understanding of device designs and mechanisms.You should have awareness of in-silico modelling approaches which support device and mechanism understanding.
Key Responsibilities:
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Providing technical leadership in order to industrialise drug delivery device platforms
- Work with internal and external project teams to establish the design space for drug delivery platforms and demonstrate robustness for commercial scale manufacture
- Design empirical test programmes to demonstrate device robustness across input specifications which meet regulatory expectations
- Engage with internal stakeholders to identify drug delivery technologies that enable the portfolio
- Engage externally to identify appropriate drug delivery technologies and perform due diligence / technical assessments
- Management of external suppliers to ensure development activities align with GSK expectations.
Basic Qualifications/Experience:
- Degree qualified in Mechanical Engineering, Biomedical Engineering, Physics or related subjects.
- Excellent understanding of mechanical principles and systems
- Experience managing external manufacturing supply bases and design consultancies
- An understanding of the principles of design for manufacture and QbD
- Evidence of problem solving and experience running technical risk assessments
- Understanding of plastic injection moulding
- Strong time management/organisational skills
- Excellent written and verbal communication skills
- Performance driven, driving for results and success with a sense of urgency
- Evidence of team working skills and flexibility
- Awareness of quality and regulatory standards associated with device development
- Awareness of in silico modelling/design tools such as FEA, MATLAB, CFD, CAD
Preferred Qualifications:
- Experience in Pharma or Medical Device development
- Experience with autoinjector development
Why GSK?
GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. This special purpose - along with our goal of being one of the world's most innovative, best performing and trusted healthcare companies - helps us attract some of the best and brightest minds in the world.
We take pride in providing access to all and continually focus on our opportunity and obligation to do more to improve inclusion and diversity: for our people inside GSK; in the way we do business; and in the communities where we operate.
We want our company to be a place where diversity of people and thought is valued everywhere and where we're all able to be ourselves and feel a sense of belonging. An inclusive organization where we all feel valued, engaged and supported, knowing that our work makes an important contribution to our mission.Reinforced by our clear values and expectations , it is part of our DNA. Together we achieve extraordinary things for our patients and consumers, who rely on us each and every day
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on , or send an email
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
About GlaxoSmithKline