Human Factors Engineer- Packaging Development and Design
- Collegeville, PA
Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Sep 25 2020
GSK is seeking a Human Factors Engineer to join our packaging development and design team in Collegeville, PA. The human factors engineer will support product development of new medicines through human factors/usability studiesincluding formative and validation studies.
Provide human factors engineering support to project teams:
- Development requirements to support design, qualification, registration, and launch key events are met.
- Develop or input into the packaging development process to incorporate usability assessments as part of new product development within the packaging development and product development community
- Collaborate with inclusive design group to establish mechanism to implement patient insight data into product development
- Conduct user tasks analyses, FMEAs, and risk assessments for new products
- Draft or review human factors plan, protocols, workplans, and associated supporting documentation
- Manage Human Factors studies with external vendors across multiple continents/geographies
- Draft or review NDA, MAA, BLA human factors sections with supporting documentation
- Provide SME guidance on RTQs
Support GSK Initiatives on Patient Focus and bringing the aspects of inclusive design into product development:
- Partnership with the inclusive design team to execute usability studies, field studies, etc. on proof of concept designs and/or pilot scale assessments
- Uses available or new tools to engage directly with patients or make use of patient insights data, and adhere to regulatory standards and legal and company ethical practices for use of such information.
Support the development of strategies on human factors engineering across the GSK:
- Globally harmonized and coordinated strategies for human factors activities
- Align with new developments and strategies of internal peers focused on human factors in the areas of devices, secondary packaging, Design to Launch, and consumer healthcare packaging
- Establish clear accountabilities for human factors engineering within different organizations
- Establish mechanism for evaluation of platform systems for multiple patient populations where available
Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:
- B.S./M.S. degree in Human Factors Engineering, Packaging Engineering/Packaging Science, Industrial Design, Product Design, Ergonomics, or 3 years' experience primarily in pharmaceutical industry.
- Experience in the pharmaceutical industry or a related field
- Experience/application of Human Factors guidances including IEC 62366, ISO 13485, ISO 14971, HE75, etc.
- Experience in developing and conducting user task analyses & risk assessments for combination products
- Experience in preparing and/or authoring planning, supportive and reporting documentation including HF planning, study screeners, informed consent, discussion guides, protocols, reports, summary reports, regulatory file documentation.
- Experience conducting formative and validation human factors studies
- Experience with design iteration and evaluation for novel packaging systems, user documentation, and combination products
Preferred Qualifications: If you have the following characteristics, it would be a plus:
- Knowledge of pharmaceutical packaging and technology, regulatory requirements, and the R&D, NPI, and technology transfer processes.
- Demonstrated ability to clearly communicate Human Factors issues / risks and potential impacts to multi-discipline teams, and effectively negotiate workable solutions / acceptable compromises.
- Demonstrated track record for accomplishment in delivering projects, working within a complex, multi-disciplinary technical organization and matrix teams, working effectively across organizational, territorial, and cultural boundaries.
- Demonstrated ability to accomplish delivery of projects, meet project milestones, and manage multiple projects.
- Demonstrated knowledge of domestic and international human factors requirements and regulations
- Demonstrated experience in regulatory module authoring and response to questions
Why GSK? Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
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.
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