Senior Automation Compliance Engineer Job
- Employer
- Merck
- Location
- Elkton VA
- Closing date
- Mar 28, 2017
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Job Details
Senior Automation Compliance Engineer-MAN004087
Description
Merck & Co., Inc., 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.
At the Merck Manufacturing facility in Elkton, Virginia, we currently have a Manufacturing Automation Compliance Senior Engineer position available.
The successful candidate will have the opportunity to apply their enthusiasm and technical skills as a member of a multidisciplinary team supporting the operation of pharmaceutical product manufacturing facilities.
Responsibilities Include:
•Lead all site based automation compliance projects and direct contract staff as necessary
•Coordinate with above site groups on corporate automation compliance initiatives
•Assess automation compliance risks, develop compliance strategies, and resolve compliance gaps
•Develop working knowledge of Quality Management Systems
•Provide on-going compliance and System Development Life Cycle (SDLC) training to department personnel
•Identify, interpret, and implement regulatory guidelines at the procedural level for SDLC Run & Operate Phase Controls
•Assess changes for validation requirements, including, but not limited to, document changes, process/equipment changes, and system changes
•Collaborate with customers and stakeholders to generate, assess, and implement process improvements
•Develop, implement, and maintain site SDLC documentation standards
•Provide regulatory compliance input to validation strategies
•Support compliance audits
•Prepare compliance reports by collecting, analyzing, and summarizing measurement data and trends
•Maintain job knowledge in alignment with current compliance engineering practices and standards; participate in continuing education opportunities and professional organizations; read professional publications; maintain personal networks
If you are the kind of individual who thrives on challenge and possess the technical, leadership and business, and communication skills that are of value to our business, we invite you to apply.
Consistently cited as a great place to work, we discover, develop, manufacture and market a wide range of vaccines and medicines to address unmet medical needs. Each of our employees is joined by an extraordinary sense of purpose - bringing Merck's finest achievements to people around the world.
Qualifications
Education Minimum Requirement:
•B.S. degree in engineering, computer science, integrated technology, or science
Required Experience and Skills:
•Seven years of relevant industry experience
•Experience implementing and maintaining validated hardware and software systems
•Working knowledge of pharmaceutical regulatory agency requirements for automation and information systems
•Experience working under cGMP
•Experience managing projects
•Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills.
Preferred Experience and Skills:
•Development and delivery of training programs
•Change management
•Management of people
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.
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Manufacturing Automation
Job Title:Sr. Spclst, Manufacturing Automation
Primary Location: NA-US-VA-Elkton
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: No
Company Trade Name:Merck
Description
Merck & Co., Inc., 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.
At the Merck Manufacturing facility in Elkton, Virginia, we currently have a Manufacturing Automation Compliance Senior Engineer position available.
The successful candidate will have the opportunity to apply their enthusiasm and technical skills as a member of a multidisciplinary team supporting the operation of pharmaceutical product manufacturing facilities.
Responsibilities Include:
•Lead all site based automation compliance projects and direct contract staff as necessary
•Coordinate with above site groups on corporate automation compliance initiatives
•Assess automation compliance risks, develop compliance strategies, and resolve compliance gaps
•Develop working knowledge of Quality Management Systems
•Provide on-going compliance and System Development Life Cycle (SDLC) training to department personnel
•Identify, interpret, and implement regulatory guidelines at the procedural level for SDLC Run & Operate Phase Controls
•Assess changes for validation requirements, including, but not limited to, document changes, process/equipment changes, and system changes
•Collaborate with customers and stakeholders to generate, assess, and implement process improvements
•Develop, implement, and maintain site SDLC documentation standards
•Provide regulatory compliance input to validation strategies
•Support compliance audits
•Prepare compliance reports by collecting, analyzing, and summarizing measurement data and trends
•Maintain job knowledge in alignment with current compliance engineering practices and standards; participate in continuing education opportunities and professional organizations; read professional publications; maintain personal networks
If you are the kind of individual who thrives on challenge and possess the technical, leadership and business, and communication skills that are of value to our business, we invite you to apply.
Consistently cited as a great place to work, we discover, develop, manufacture and market a wide range of vaccines and medicines to address unmet medical needs. Each of our employees is joined by an extraordinary sense of purpose - bringing Merck's finest achievements to people around the world.
Qualifications
Education Minimum Requirement:
•B.S. degree in engineering, computer science, integrated technology, or science
Required Experience and Skills:
•Seven years of relevant industry experience
•Experience implementing and maintaining validated hardware and software systems
•Working knowledge of pharmaceutical regulatory agency requirements for automation and information systems
•Experience working under cGMP
•Experience managing projects
•Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills.
Preferred Experience and Skills:
•Development and delivery of training programs
•Change management
•Management of people
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.
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Manufacturing Automation
Job Title:Sr. Spclst, Manufacturing Automation
Primary Location: NA-US-VA-Elkton
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: No
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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