Johnson & Johnson companies are equal opportunity employers.
TECHNICAL OPERATIONS SITE DIRECTOR - LANCASTER, PA SITE-0511140724
Description
McNeil Consumer Healthcare Division, a member of Johnson & Johnson's Family of Companies, is recruiting for a Technical Operations Site Director for the Lancaster, PA site.
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, IMODIUM® A-D anti-diarrheal, MOTRIN® IB, and SUDAFED® nasal decongestants.
The Technical Operations Site Director provides technical leadership and direction for Equipment Engineering, Process Engineering, Package Engineering, and Validation functions at the Lancaster, PA manufacturing site. Representing Technical Operations, the position is a key member of the Manufacturing Site Leadership Team in collaboration with Manufacturing, Quality Assurance, Planning/Logistics, and other site functions. Ensures full alignment of the site-based Technical Operations team with the site’s objectives, goals, and compliance metrics. Manages performance of Tech Ops Base Business personnel in accordance with business goals and the J&J Leadership Imperatives model. Manages the site Technical Operations budget, including cost control and spending prioritization to meet site objectives. Ensures alignment of site activities with Solid Dose technology platform and Center of Excellence strategies. Responsible for the validated state of processes and products at the site in compliance with cGMP’s and applicable regulations following J&J policies and procedures. This includes new product introduction, product re-launch activities, changes to existing manufacturing processes and equipment, changes in raw materials and re-validation/re-qualification activities arising from CAPA or periodic reviews.
The Site Director is responsible for the resolution of complex technical issues and investigations. Provides support to the Base Business in matters such as investigations, manufacturing equipment reliability, process improvement projects, product customer complaints and support to audits and inspections. Prioritizes resources in collaboration with the site and technology platforms to drive flawless execution of manufacturing equipment and process related projects. Serves as Co-Chairperson (with Quality partner) of the site’s Validation Review Committee and is responsible for periodic review of Process, Manufacturing Equipment, and Cleaning validated states and management of change as relates to qualified/validated state. Represents Site Master Plans (SMP) and supports SMP execution with site leadership team.
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, create & maintain an environment that promotes employee involvement and doing things right the first time
Qualifications
A Bachelor’s Degree in Engineering, Science, Pharmacy or other technical discipline is required. A minimum of Twelve (12) years of experience in a GMP regulated manufacturing plant environment is required. Experience within the OTC, Consumer, pharmaceutical industry is highly preferred. At least five (5) years of people management experience is required. Working experience in domestic or international regulatory inspections is required. Experience in one or more of the following areas is required: product/process development of pharmaceutical/OTC /Medical Device products; manufacturing of pharmaceutical/OTC/Medical Device products; Technical Services or Engineering or R&D in pharmaceutical/OTC industries.
Candidate must have a strong knowledge and application of FDA and ICH regulatory requirements and latest guidance in the development, validation, and manufacture of pharmaceutical or OTC products and qualification of manufacturing equipment is required. Must possess the ability to collaborate with and influence manufacturing site leadership teams regarding prioritization and resourcing. Ability to inform, communicate with, and influence Senior Management regarding validated state of respective products/processes and indicated priorities is necessary.
Knowledge and application of pharmaceutical or OTC product and process development; life-cycle management of this class of products including strategies for continuous improvement is required. Experience with capital appropriations, equipment installation and qualification is preferred. Knowledge and application of pharmaceutical or OTC manufacturing and formulation technologies for solid dose manufacturing and product development is preferred. Must be able to lead teams in problem-solving and decision-making, and collaborate with and influence business partner leaders with a focus on data, science, and technology. Demonstrated ability to constructively challenge cross-functional project teams and business partners to achieve project goals and McNeil strategic plans.
Strong statistical understanding and application including Design of Experiments and statistical analysis is preferred. Good understanding and application of finance and budget management is required. Strong collaboration, communication, technical writing, and presentation skills are required. Demonstrated skills with talent development, ability to mentor, coach, and develop future leaders are required. Computer skills including common Microsoft applications (Word, Excel, Powerpoint, Visio) are required. Six-Sigma and Lean Manufacturing training and/or certifications is preferred.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-Pennsylvania-Lancaster
Organization: McNeil-PPC, Inc. (6101)
Job Function: Operations (Generalist)
Relocation: Eligible Yes - Within Country
Travel:Yes, 10 % of the Time
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
TECHNICAL OPERATIONS SITE DIRECTOR - LANCASTER, PA SITE-0511140724
Description
McNeil Consumer Healthcare Division, a member of Johnson & Johnson's Family of Companies, is recruiting for a Technical Operations Site Director for the Lancaster, PA site.
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, IMODIUM® A-D anti-diarrheal, MOTRIN® IB, and SUDAFED® nasal decongestants.
The Technical Operations Site Director provides technical leadership and direction for Equipment Engineering, Process Engineering, Package Engineering, and Validation functions at the Lancaster, PA manufacturing site. Representing Technical Operations, the position is a key member of the Manufacturing Site Leadership Team in collaboration with Manufacturing, Quality Assurance, Planning/Logistics, and other site functions. Ensures full alignment of the site-based Technical Operations team with the site’s objectives, goals, and compliance metrics. Manages performance of Tech Ops Base Business personnel in accordance with business goals and the J&J Leadership Imperatives model. Manages the site Technical Operations budget, including cost control and spending prioritization to meet site objectives. Ensures alignment of site activities with Solid Dose technology platform and Center of Excellence strategies. Responsible for the validated state of processes and products at the site in compliance with cGMP’s and applicable regulations following J&J policies and procedures. This includes new product introduction, product re-launch activities, changes to existing manufacturing processes and equipment, changes in raw materials and re-validation/re-qualification activities arising from CAPA or periodic reviews.
The Site Director is responsible for the resolution of complex technical issues and investigations. Provides support to the Base Business in matters such as investigations, manufacturing equipment reliability, process improvement projects, product customer complaints and support to audits and inspections. Prioritizes resources in collaboration with the site and technology platforms to drive flawless execution of manufacturing equipment and process related projects. Serves as Co-Chairperson (with Quality partner) of the site’s Validation Review Committee and is responsible for periodic review of Process, Manufacturing Equipment, and Cleaning validated states and management of change as relates to qualified/validated state. Represents Site Master Plans (SMP) and supports SMP execution with site leadership team.
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, create & maintain an environment that promotes employee involvement and doing things right the first time
Qualifications
A Bachelor’s Degree in Engineering, Science, Pharmacy or other technical discipline is required. A minimum of Twelve (12) years of experience in a GMP regulated manufacturing plant environment is required. Experience within the OTC, Consumer, pharmaceutical industry is highly preferred. At least five (5) years of people management experience is required. Working experience in domestic or international regulatory inspections is required. Experience in one or more of the following areas is required: product/process development of pharmaceutical/OTC /Medical Device products; manufacturing of pharmaceutical/OTC/Medical Device products; Technical Services or Engineering or R&D in pharmaceutical/OTC industries.
Candidate must have a strong knowledge and application of FDA and ICH regulatory requirements and latest guidance in the development, validation, and manufacture of pharmaceutical or OTC products and qualification of manufacturing equipment is required. Must possess the ability to collaborate with and influence manufacturing site leadership teams regarding prioritization and resourcing. Ability to inform, communicate with, and influence Senior Management regarding validated state of respective products/processes and indicated priorities is necessary.
Knowledge and application of pharmaceutical or OTC product and process development; life-cycle management of this class of products including strategies for continuous improvement is required. Experience with capital appropriations, equipment installation and qualification is preferred. Knowledge and application of pharmaceutical or OTC manufacturing and formulation technologies for solid dose manufacturing and product development is preferred. Must be able to lead teams in problem-solving and decision-making, and collaborate with and influence business partner leaders with a focus on data, science, and technology. Demonstrated ability to constructively challenge cross-functional project teams and business partners to achieve project goals and McNeil strategic plans.
Strong statistical understanding and application including Design of Experiments and statistical analysis is preferred. Good understanding and application of finance and budget management is required. Strong collaboration, communication, technical writing, and presentation skills are required. Demonstrated skills with talent development, ability to mentor, coach, and develop future leaders are required. Computer skills including common Microsoft applications (Word, Excel, Powerpoint, Visio) are required. Six-Sigma and Lean Manufacturing training and/or certifications is preferred.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-Pennsylvania-Lancaster
Organization: McNeil-PPC, Inc. (6101)
Job Function: Operations (Generalist)
Relocation: Eligible Yes - Within Country
Travel:Yes, 10 % of the Time
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