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Senior Process/Compliance Engineer. Job in Wilson, North Carolina, United States in Merck & Co., Inc.. Nelest.com
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Senior Process/Compliance Engineer

col-narrow-left   

Job ID:

22227

Location:

Wilson, NC 

Job function:

Engineering, Logistics
col-narrow-right   

Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Senior Process/Compliance Engineer

Job Description:

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.

As the cornerstone of Merck's Primary US Packaging Site, the Packaging Operations Areas are seeking highly motivated individuals to partner with Quality Operations, MPS, and Engineering. These individuals will provide technical support for floor operations in a range of capacities ranging from analysis of operating performance, management of key operational data within SAP, application of advanced problem solving capabilities, strengthening compliance posture and inspection readiness, and investigating and authoring deviations related to unplanned events.

The position requires strong technical writing skills and problem solving skills for conducting scientific investigations and data analysis to determine root cause, product impact and develop corrective actions for unexpected results. Enthusiasm for continuously learning is a requirement. The individual must embrace and be committed to establishing an empowered team culture, with the goal of each employee reaching their fullest potential and having accountability, authority and responsibility to one another, our community, and our patients.

Primary Activities associated with the position include:








-Identify and implement technology-driven productivity improvements.
-Ownership of Quality System Chapters and development of Subject matter expertise.
-Identify and solve a range of problems in complex situations, analyze possible solutions and assess each via standard procedures. Demonstrate proficiency developing processes to minimize cost and maintain process consistency.
-Collaborate independently with Engineering Change Management personnel to facilitate execution.
-Manage small/medium scale projects across the Operations area related to changes supporting increased reliability, demonstration of new technology, or enhanced compliance.
-Responsible for coordinating, developing and implementing Corrective Action/ Preventive Action (CAPA) plans. Author deviations as required.
-Leads trouble-shooting efforts and effectively resolves and author investigations for manufacturing atypical events.
-Develops and implements corrective actions to unplanned (atypical) manufacturing events to ensure consistent and reliable product supply. Works as part of the deviation reduction team to drive high level corrective actions to automate/eliminate root cause conditions to prevent recurrences. Represents operations in deviation reduction meetings/huddles.
-Tracks and trends operating performance (metrics) and works cross-functionally to drive required actions.
-Evaluates worker productivity and recommends improvements to increase manpower efficiency.
-Accountable for technical contribution to project teams and will be expected to manage lead/small projects.
-Demonstrates understanding of Standardized Work principles and identifies targets for implementation within the Operations and Business Processes, and develops Standardized Work Instructions to improve training and routine execution of task.
-Engages with the continuous improvement team to drive changes that reduce lead times, improves quality, and mitigates cost.
-Maintain current state data for operational run rates, operational performance (OEE with Reliability Engineering). Utilizes data to drive productivity improvement.
-Develop Standardized Work for Operations and Business Processes















Note: Off-shift and weekend work as required for this position.


Travel: Yes, 5 % of the Time

Job Requirements:

Qualifications

Education Minimum Requirement:


-Bachelor of Science in Engineering field


Required Experience and Skills:


-B.S. in Engineering, and a minimum of 5 years of relevant industrial experience
-Demonstrated ability to work independently.
-Relevant work experience encompassing a working knowledge of FDA regulatory requirements
-Excellent leadership, strong communication (written and oral), interpersonal and supervisory skills.
-Technical writing knowledge and experience, i.e. documentation of scientific data
-A sound knowledge and/or experience with optimization processes and/or equipment
-Enthusiasm, confidence and the ability to take initiative for continuous improvement and learning
-Knowledge and/or experience with formal problem solving techniques as it relates to a hands-on approach to problem solving,
-techniques as it relates to a hands-on approach to problem solving
Preferred Experience and Skills:
-Relevant work experience encompassing a working knowledge of FDA regulatory requirements
-cGMP experience in a pharmaceutical packaging environment
-Formal training with Lean Six Sigma tools and certifications
-Knowledge and/or experience with formal problem solving techniques as it relates to a hands-on approach to problem solving, such as root cause analysis and/or Lean Six Sigma tools
-Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry
-Technical writing experience with investigations, change requests, standard operating procedures, batch records, protocols
-Knowledge of SAP
-Strong Change Execution Management Skills
-Demonstrated data analysis skills using advanced functionality in excel, Parsec, Microsoft access, statistical software packages (Minitab)

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.

Zip Code:

27895

Company Info
Merck & Co., Inc.

Kenilworth, NJ, United States

Phone:
Web Site: merck.com

Company Profile

Company Info


Merck & Co., Inc.
Kenilworth, NJ, United States
Phone:
Web Site: merck.com

Senior Process/Compliance Engineer

col-narrow-left   

Job ID:

22227

Location:

Wilson, NC 

Job function:

Engineering, Logistics
col-narrow-right   

Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Senior Process/Compliance Engineer

Job Description:

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.

As the cornerstone of Merck's Primary US Packaging Site, the Packaging Operations Areas are seeking highly motivated individuals to partner with Quality Operations, MPS, and Engineering. These individuals will provide technical support for floor operations in a range of capacities ranging from analysis of operating performance, management of key operational data within SAP, application of advanced problem solving capabilities, strengthening compliance posture and inspection readiness, and investigating and authoring deviations related to unplanned events.

The position requires strong technical writing skills and problem solving skills for conducting scientific investigations and data analysis to determine root cause, product impact and develop corrective actions for unexpected results. Enthusiasm for continuously learning is a requirement. The individual must embrace and be committed to establishing an empowered team culture, with the goal of each employee reaching their fullest potential and having accountability, authority and responsibility to one another, our community, and our patients.

Primary Activities associated with the position include:








-Identify and implement technology-driven productivity improvements.
-Ownership of Quality System Chapters and development of Subject matter expertise.
-Identify and solve a range of problems in complex situations, analyze possible solutions and assess each via standard procedures. Demonstrate proficiency developing processes to minimize cost and maintain process consistency.
-Collaborate independently with Engineering Change Management personnel to facilitate execution.
-Manage small/medium scale projects across the Operations area related to changes supporting increased reliability, demonstration of new technology, or enhanced compliance.
-Responsible for coordinating, developing and implementing Corrective Action/ Preventive Action (CAPA) plans. Author deviations as required.
-Leads trouble-shooting efforts and effectively resolves and author investigations for manufacturing atypical events.
-Develops and implements corrective actions to unplanned (atypical) manufacturing events to ensure consistent and reliable product supply. Works as part of the deviation reduction team to drive high level corrective actions to automate/eliminate root cause conditions to prevent recurrences. Represents operations in deviation reduction meetings/huddles.
-Tracks and trends operating performance (metrics) and works cross-functionally to drive required actions.
-Evaluates worker productivity and recommends improvements to increase manpower efficiency.
-Accountable for technical contribution to project teams and will be expected to manage lead/small projects.
-Demonstrates understanding of Standardized Work principles and identifies targets for implementation within the Operations and Business Processes, and develops Standardized Work Instructions to improve training and routine execution of task.
-Engages with the continuous improvement team to drive changes that reduce lead times, improves quality, and mitigates cost.
-Maintain current state data for operational run rates, operational performance (OEE with Reliability Engineering). Utilizes data to drive productivity improvement.
-Develop Standardized Work for Operations and Business Processes















Note: Off-shift and weekend work as required for this position.


Travel: Yes, 5 % of the Time

Job Requirements:

Qualifications

Education Minimum Requirement:


-Bachelor of Science in Engineering field


Required Experience and Skills:


-B.S. in Engineering, and a minimum of 5 years of relevant industrial experience
-Demonstrated ability to work independently.
-Relevant work experience encompassing a working knowledge of FDA regulatory requirements
-Excellent leadership, strong communication (written and oral), interpersonal and supervisory skills.
-Technical writing knowledge and experience, i.e. documentation of scientific data
-A sound knowledge and/or experience with optimization processes and/or equipment
-Enthusiasm, confidence and the ability to take initiative for continuous improvement and learning
-Knowledge and/or experience with formal problem solving techniques as it relates to a hands-on approach to problem solving,
-techniques as it relates to a hands-on approach to problem solving
Preferred Experience and Skills:
-Relevant work experience encompassing a working knowledge of FDA regulatory requirements
-cGMP experience in a pharmaceutical packaging environment
-Formal training with Lean Six Sigma tools and certifications
-Knowledge and/or experience with formal problem solving techniques as it relates to a hands-on approach to problem solving, such as root cause analysis and/or Lean Six Sigma tools
-Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry
-Technical writing experience with investigations, change requests, standard operating procedures, batch records, protocols
-Knowledge of SAP
-Strong Change Execution Management Skills
-Demonstrated data analysis skills using advanced functionality in excel, Parsec, Microsoft access, statistical software packages (Minitab)

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.

Zip Code:

27895
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