Johnson & Johnson companies are equal opportunity employers.
SR PACKAGING VALIDATION ENGINEER-8938140606
Description
McNeil Consumer Healthcare Division of McNeil-PPC, Inc is currently recruiting for a Senior Engineer Packaging Validation, located in Lancaster, PA.
McNeil Consumer Healthcare Division of McNeil-PPC, Inc. markets a broad range of over-the-counter products, including TYLENOL®, ZYRTEC®, BENADRYL®, IMODIUM® A-D, MOTRIN® IB, and SUDAFED®.
The Senior Engineer Packaging Validation leads, plans and executes complex packaging validation and equipment qualification activities for NA OTC Operations with primary focus on the McNeil Lancaster facility. Activities include but are not limited to: execution of packaging equipment qualifications, packaging validations, support of continuous improvement initiatives, support of operational readiness of packaging and support to the resolution of packaging business interruptions. He/she will leverage best practices for validation, standards and knowledge from across the organization.
This role is responsible for creating and executing all packaging validation and packaging equipment qualification documents. The candidate will become a subject matter expert for validation execution, validation monitoring and validation SOP’s at the McNeil Lancaster Facility. The candidate has prior hands on experience with OTC and/or Pharmaceutical packaging processes and validations. Prior experience in specifying packaging equipment and/or components is a plus.
The Senior Engineer Packaging Validation will have knowledge of qualification activities needed to support validation and validation monitoring processes. The candidate will possess the ability to write, review and approve multiple source documents necessary to identify critical technical and compliance requirements. Furthermore, the candidate will develop recommendations to simplify existing packaging validation procedures while meeting compliance requirements.
The primary function of this role is the execution of current packaging validation processes and procedures. This individual will partner both intra and interdepartmentally. In addition, the Senior Engineer Packaging Validation will be responsible to:
Review of qualification documentation (IQ/OQ) and/or performing equipment qualifications following the SD&V process. Review packaging equipment information to support packaging validation activities Clearly communicate McNeil Validation SOP requirements. Assess current documents against current standards. Create Validation Batch Records. Author and Execute Pkg-VIA, Pkg-PQ and Pkg-PPQ protocols and reports. Author Packaging Validation Project Plans and/or Packaging Validation Master Plans. Perform and Maintain the Packaging Process Monitoring Program
All McNeil employees are required to cultivate an environment of quality & compliance in their actions. This includes attending all required training, adhering to the processes & procedures of their role and the company and displaying the highest level of integrity. Those who manage others are required to ensure their employees are trained appropriately, as well as create and maintain an environment that promotes employee involvement and doing things right the first time.
Qualifications
A minimum of a Bachelors of Science degree in Engineering or Technical discipline is required. A minimum of 5 years of industry experience is required, at least 3 years of Packaging Equipment Validation or Operations experience is preferred. Specific experience within the Consumer Goods, OTC, or Pharmaceutical industry is required. GMP experience is preferred. Experience in a highly regulated environment is preferred. Demonstrated technical knowledge related to packaging equipment qualification and validation is required. Ability to work and lead in a cross functional environment is required. Previous experience focusing on managing and/or supporting technical projects, establishing project success criteria and monitoring of activities is required. Proficiency in MS Office applications is required, especially with Excel and PowerPoint. Experience in customer focus, program/project management, accountability, process orientation, and strategic thinking is required.
Experience in process excellence and process thinking and application of tools is preferred. Six Sigma or Process Excellence certification is preferred. Negotiation skills, ability to effectively work with peers, strong leadership and analytical skills are preferred. The ability to establish project criteria, to monitor activities and to successfully execute several projects concurrently is required.
This role is based in Lancaster, PA and may require an average of 25% travel based on business needs.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies
J2W:LI
Primary Location:North America-United States-Pennsylvania-Lancaster
Organization: McNeil-PPC, Inc. (6101)
Job Function: Packaging
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
SR PACKAGING VALIDATION ENGINEER-8938140606
Description
McNeil Consumer Healthcare Division of McNeil-PPC, Inc is currently recruiting for a Senior Engineer Packaging Validation, located in Lancaster, PA.
McNeil Consumer Healthcare Division of McNeil-PPC, Inc. markets a broad range of over-the-counter products, including TYLENOL®, ZYRTEC®, BENADRYL®, IMODIUM® A-D, MOTRIN® IB, and SUDAFED®.
The Senior Engineer Packaging Validation leads, plans and executes complex packaging validation and equipment qualification activities for NA OTC Operations with primary focus on the McNeil Lancaster facility. Activities include but are not limited to: execution of packaging equipment qualifications, packaging validations, support of continuous improvement initiatives, support of operational readiness of packaging and support to the resolution of packaging business interruptions. He/she will leverage best practices for validation, standards and knowledge from across the organization.
This role is responsible for creating and executing all packaging validation and packaging equipment qualification documents. The candidate will become a subject matter expert for validation execution, validation monitoring and validation SOP’s at the McNeil Lancaster Facility. The candidate has prior hands on experience with OTC and/or Pharmaceutical packaging processes and validations. Prior experience in specifying packaging equipment and/or components is a plus.
The Senior Engineer Packaging Validation will have knowledge of qualification activities needed to support validation and validation monitoring processes. The candidate will possess the ability to write, review and approve multiple source documents necessary to identify critical technical and compliance requirements. Furthermore, the candidate will develop recommendations to simplify existing packaging validation procedures while meeting compliance requirements.
The primary function of this role is the execution of current packaging validation processes and procedures. This individual will partner both intra and interdepartmentally. In addition, the Senior Engineer Packaging Validation will be responsible to:
Review of qualification documentation (IQ/OQ) and/or performing equipment qualifications following the SD&V process. Review packaging equipment information to support packaging validation activities Clearly communicate McNeil Validation SOP requirements. Assess current documents against current standards. Create Validation Batch Records. Author and Execute Pkg-VIA, Pkg-PQ and Pkg-PPQ protocols and reports. Author Packaging Validation Project Plans and/or Packaging Validation Master Plans. Perform and Maintain the Packaging Process Monitoring Program
All McNeil employees are required to cultivate an environment of quality & compliance in their actions. This includes attending all required training, adhering to the processes & procedures of their role and the company and displaying the highest level of integrity. Those who manage others are required to ensure their employees are trained appropriately, as well as create and maintain an environment that promotes employee involvement and doing things right the first time.
Qualifications
A minimum of a Bachelors of Science degree in Engineering or Technical discipline is required. A minimum of 5 years of industry experience is required, at least 3 years of Packaging Equipment Validation or Operations experience is preferred. Specific experience within the Consumer Goods, OTC, or Pharmaceutical industry is required. GMP experience is preferred. Experience in a highly regulated environment is preferred. Demonstrated technical knowledge related to packaging equipment qualification and validation is required. Ability to work and lead in a cross functional environment is required. Previous experience focusing on managing and/or supporting technical projects, establishing project success criteria and monitoring of activities is required. Proficiency in MS Office applications is required, especially with Excel and PowerPoint. Experience in customer focus, program/project management, accountability, process orientation, and strategic thinking is required.
Experience in process excellence and process thinking and application of tools is preferred. Six Sigma or Process Excellence certification is preferred. Negotiation skills, ability to effectively work with peers, strong leadership and analytical skills are preferred. The ability to establish project criteria, to monitor activities and to successfully execute several projects concurrently is required.
This role is based in Lancaster, PA and may require an average of 25% travel based on business needs.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies
J2W:LI
Primary Location:North America-United States-Pennsylvania-Lancaster
Organization: McNeil-PPC, Inc. (6101)
Job Function: Packaging
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
