Senior Specialist, Human Factors Engineering(Combination Products) Job

Employer
Merck
Location
West Point, PA, US
Posted
September 04 2017
Organization Type
Pharma
Senior Specialist, Human Factors Engineering(Combination Products)-PAC000229

Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

Reporting to the Director of Packaging Commercialization the incumbent will be responsible for planning, coordination, execution, and reporting of human factors studies in support of combination product user interface development. This position will interact with cross functional teams and with all levels of employees. Activities will include preparing use and user characterization documentation, test protocols, and summary evaluation documentation. The Senior specialist will be responsible for coordinating vendor managed activities and evaluating and interpreting reports, as well as updating documentation packages and guiding development activities as needed based on outcomes and in support of project schedules. The Senior Specialist will execute responsibilities based on current regulatory guidance including FDA, EU, ISO, and other applicable regulatory frameworks. Adherence to applicable Medical Device and Combination Product Current Good Manufacturing Practices (CGMPs), and Merck internal requirements is expected.


Primary Responsibilities Include:

- Supports execution of human factors studies in alignment with development project schedules.

- Participates on Merck cross functional teams to ensure appropriate study design, and integration of results into the development documentation packages

- Works with the External and Internal Partners to generate study protocols, reports, and coordinate availability of execution materials.

- Provides support in the gathering of metrics, procedural updates and business systems development.

- Provides proactive support in training and coaching to cross functional team members as needed to support the integration of human factors deliverables.

- Executes work functions in approved formats and as aligned with 21 CFR Part 820 regulations, IEC 63266, and other applicable standards.

- Supports preparations for regulatory filings of new products.

- Remains informed of current GMP requirements and industry trends as described in worldwide regulations and industry standards.

- Maintains a subject matter expert level of knowledge related to human factors engineering.

Qualifications

Education:

- Bachelor’s degree in appropriate Science or Engineering discipline

Required:

- Minimum of five (5) years’ experience with B.S.; M.S. and three (3) years’ experience; or Ph.D. in pharmaceutical / engineering / academia with human factors.

- Expert knowledge of medical device and combination product regulations and compliance in the area of human factors engineering with experience in their application, including current GMPs for combination products.

- Demonstrated ability to work effectively in teams and adhere to project plans.

- Demonstrated capabilities in medical device risk management.

- Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others.

- Highly effective written and oral communicator.

Preferred:

- Working knowledge of technical aspects of medical device development and commercialization.

- Experience in usability/customer focused principles or related fields (e.g. clinical psychology, ergonomics, marketing)

- Development, product approval, and/or inspection experience with the medical device constituent of a combination product is an asset.

- Experience interacting with regulatory bodies.

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Packaging Engineering

Job Title:Assoc. Dir, Engineering

Primary Location: NA-US-PA-West Point

Other Locations: NA-US-NJ-Whitehouse Station West, NA-US-NJ-Rahway, NA-US-NJ-Kenilworth

Employee Status: Regular

Travel: Yes, 15 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Company Trade Name:Merck