Principal cleaning validation scientist job

Company Name:
J&J Family of Companies
Johnson & Johnson companies are equal opportunity employers.
McNeil Consumer Healthcare is currently recruiting for a Principal Scientist, Cleaning Validation located in Lancaster, PA.
McNeil Consumer Healthcare markets a broad range of over-the-counter products, including TYLENOL acetaminophen products; BENADRYL , ZYRTEC and ZYRTEC -D allergy medicines; IMODIUM A-D anti-diarrheal; MOTRIN IB; and SUDAFED and SUDAFED PE nasal decongestants
McNeil Consumer Healthcare is currently recruiting for a Principal Scientist, Cleaning Validation. The Principal Scientist will be responsible for the cleaning validation of OTC Monograph drug products. This individual must be well versed in the principles and approaches of product/equipment cleaning validation. This individual will be responsible for providing hands on technical support in the design, development, and the implementation of a successful cleaning validation program meeting FDA requirements for products manufactured within the McNeil Lancaster manufacturing facility. The cleaning validation program scope includes the cleaning of Solid dosage products and associated equipment. This individual will be accountable to the Lancaster Cleaning Validation Manager. The Cleaning Validation Principal Scientist will lead junior staff and project teams, as well as, provide hands on support and technical project management in the execution and maintenance of the validation program, including: development of product/equipment cleaning procedures, study/protocol design, documentation, cleaning validation execution, cleaning monitoring and general maintenance of the facility cleaning validation program and Cleaning Validation Master Plan. This individual is expected to be a leader/SME within the manufacturing facility as it relates to cleaning validation activities and must have the ability to gain alignment, advise, coach and train personnel facility wide on validation requirements. Validation documentation must be completed using good science and at a quality level that meets the established FDA and Johnson & Johnson Quality Compliance standards. This individual will work cross functionally in a team environment with other groups within the McNeil facility. This position reports to the Lancaster Cleaning Validation Manager, Technical Operations.
A minimum of a Bachelor's degree is required. A degree in Chemical Engineering/Industrial Pharmacy or related field of study is preferred. A minimum of 7 years cleaning validation experience in support of a commercial manufacturing facility is required.
Experience in cleaning validation within an FDA regulated manufacturing environment is required. A strong knowledge of the principals of cleaning validation, current industry approaches and the FDA validation guidance's are required. An in-depth understanding of cGMP's and current industry / FDA Compliance requirements is required. An in-depth knowledge of cleaning validation of solid/liquid dosage forms and/or solids/liquid processing equipment is required.
The candidate must be able to work independently with minimum supervision and have excellent oral and written communication skills. This candidate should have proven technical leadership skills and an ability to work collaboratively across functional groups and manage Project Teams in the execution of project activities. This candidate must be a problem solver; detail oriented, and must be able to handle multiple responsibilities and projects. This candidate is expected to interact independently with team members, business, Quality and research partners, as well as the management of functional groups across the manufacturing enterprise in accomplishing cleaning team project goals and objectives.
Candidates must be able to occasionally lift and/or carry equipment between 25 to 35 lbs., and must be able to lift from the ground to waist.
This position will be located in Lancaster, PA with some travel between McNeil manufacturing sites, as necessary.
If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today!
Primary Location: North America-United States-Pennsylvania-Lancaster
Organization: McNeil-PPC, Inc. (6101)
Job Function: Process Engineering
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
Req ID: 5720140307
Date: Tue, 11 03 2014 00:00:00 GMT
Country: US
State: PA
City: Lancaster
Postal Code: 17573
Locale: en_US

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