Associate Director, Packaging & Combination Product Engineer Job
- Employer
- Merck
- Location
- West Point PA
- Closing date
- Oct 17, 2016
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Job Details
Associate Director, Packaging & Combination Product Engineer-PAC000193
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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Description:
The Associate Director, Packaging & Combination Product Engineer will report to the Director of Packaging Commercialization (solids and specialty devices). The successful candidate will focus on medical device & package development for delivery of traditional pharmaceuticals (solid dosage, oral powders, and suspensions) and combination products.
The successful candidate will have direct leadership experience and have demonstrated project execution pertaining to Medical Device/Combination Product Design Development & Control, Human factors engineering, Combination Product design verification, transfer and validation, primary packaging, and Design History Files. They will ensure appropriate design control strategy and document control processes are followed in completion of designated project activities.
Responsibilities:
- The candidate will be expected to build inclusive collaborative partnerships with internal and external stake-holders such as marketing, commercial manufacturing, commercial planning, analytical operations and other relevant development groups, so an understanding of the relationships between formulation, primary packaging, process, and device design is required.
- The successful candidate will provide leadership in selecting off the shelf device components including establishing component specifications, test methods /validation as needed.
- The successful candidate will display ownership and make informed cost/ benefit decisions based on analysis of inputs, outcomes, risks and likely return.
Qualifications
Education Requirements:
- PhD, MS, or BS degree with 10+ years of experience in a related scientific discipline (Preferred Chemical Engineering, Packaging Science, Mechanical Engineering, Pharmaceutical Sciences or similar).
Required:
- Combination product packaging experience.
- Work experience must demonstrate leadership and expertise in medical device and combination product development.
- Excellent communication skills (both verbal and written) and interpersonal skills are required.
- Demonstrated experience in building collaborative partnerships with cross-functional groups both internally and externally.
- Author/review global Regulatory submissions.
- Knowledge of current US, and global Regulations, ICH guidance, ISO standards, and quality system regulations for combination products.
- Experience in developing and commercializing devices/combination products under Design Controls (21CFR820), Quality Systems requirements (ISO 13485) and execution of Risk Management processes and tools (ISO 14971).
- Demonstrated project management experience and ability to provide technical leadership for complex projects.
- Must possess independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. 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:
EEOC Poster
EEOC GINA Supplement
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
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: None
Company Trade Name:Merck
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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Description:
The Associate Director, Packaging & Combination Product Engineer will report to the Director of Packaging Commercialization (solids and specialty devices). The successful candidate will focus on medical device & package development for delivery of traditional pharmaceuticals (solid dosage, oral powders, and suspensions) and combination products.
The successful candidate will have direct leadership experience and have demonstrated project execution pertaining to Medical Device/Combination Product Design Development & Control, Human factors engineering, Combination Product design verification, transfer and validation, primary packaging, and Design History Files. They will ensure appropriate design control strategy and document control processes are followed in completion of designated project activities.
Responsibilities:
- The candidate will be expected to build inclusive collaborative partnerships with internal and external stake-holders such as marketing, commercial manufacturing, commercial planning, analytical operations and other relevant development groups, so an understanding of the relationships between formulation, primary packaging, process, and device design is required.
- The successful candidate will provide leadership in selecting off the shelf device components including establishing component specifications, test methods /validation as needed.
- The successful candidate will display ownership and make informed cost/ benefit decisions based on analysis of inputs, outcomes, risks and likely return.
Qualifications
Education Requirements:
- PhD, MS, or BS degree with 10+ years of experience in a related scientific discipline (Preferred Chemical Engineering, Packaging Science, Mechanical Engineering, Pharmaceutical Sciences or similar).
Required:
- Combination product packaging experience.
- Work experience must demonstrate leadership and expertise in medical device and combination product development.
- Excellent communication skills (both verbal and written) and interpersonal skills are required.
- Demonstrated experience in building collaborative partnerships with cross-functional groups both internally and externally.
- Author/review global Regulatory submissions.
- Knowledge of current US, and global Regulations, ICH guidance, ISO standards, and quality system regulations for combination products.
- Experience in developing and commercializing devices/combination products under Design Controls (21CFR820), Quality Systems requirements (ISO 13485) and execution of Risk Management processes and tools (ISO 14971).
- Demonstrated project management experience and ability to provide technical leadership for complex projects.
- Must possess independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. 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:
EEOC Poster
EEOC GINA Supplement
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
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: None
Company Trade Name:Merck
Company
Our vision is to make a difference in the lives of people globally through our innovative medicines, vaccines, biologic therapies, consumer health and animal products. We aspire to be the best healthcare company in the world and are dedicated to providing leading innovations and solutions for tomorrow.
We have made it our mission to provide innovative, distinctive products and services that save and improve lives, satisfy customer needs and to be recognized as a great place to work
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