Job Title

　　Principal Quality Engineer

　　Requisition

　　JR000013802 Principal Quality Engineer (Open)

　　Location

　　Greenville, IL (Pharma) - USA034

　　Additional Locations

　　Greenville, IL

　　Job Description

　　SUMMARY OF POSITION:

　　Provides overall Quality Assurance (QA) management of the batch record review, manufacturing (current Good Manufacturing Practices) cGMP compliance, and product release functions for the manufacturing of pharmaceutical products. Provides QA and cGMP compliance leadership regarding Quality systems and adherence to site, corporate, and regulatory requirements. Key leadership position within the Quality group.

　　ESSENTIAL FUNCTIONS:

　　Manage the QA team responsible for batch record review, product release, label issuance, sampling and sample management activities

　　Write, review and approve exceptions, change controls, and CAPA in the quality system.

　　Review and approve out of specification and customer complaint investigations in quality system.

　　Lead strategic Quality continuous improvement efforts and projects

　　Provide expertise to support site transition to align with drug product expectations

　　Lead auditor for the site internal audit system

　　Follow all internal and basic cGMP guidelines for pharmaceutical operations

　　Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal polices to assure compliance

　　Ability to identify, evaluate and remediate gaps as they pertain to data integrity

　　Provides solutions to technical problems of moderate scope and complexity

　　Adhere to all safety rules and maintain 100% completion of all safety required training

　　DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

　　MINIMUM REQUIREMENTS:

　　Education:

　　BS in Chemistry, Chemical Engineering, related science or equivalent combination of education, experience, and competencies.Experience:

　　Minimum of 8 years experience in Quality Control/ Quality Assurance in a pharmaceutical manufacturing environment. ASQ CQA certification preferred. Proven personnel and project management history. Complete knowledge of FDA Code of Federal Regulations (CFR) and International Conference Harmonization (ICH) guidelines, pharmaceutical regulations including current GXP, GLP, or GMP requirementsPreferred Skills/Qualifications:

　　Excellent communication and leadership skills.

　　Ability to work in and promote a team environment.

　　Working knowledge of Six Sigma and/or Lean manufacturing tools.

　　Complete understanding and application of principles, concepts, practices, and standards within discipline.

　　Ability to lead and influence people.

　　Understanding of basic statistical principles

　　Expert knowledge of cGMP guidelines and knowledge of US and International pharmaceutical manufacturing regulations.

　　Bias toward change, management of change, and achievement of results

　　Exercises considerable latitude in determining technical objectives of assignment

　　Demonstrated ability to make risk based decisions regarding product quality and regulatory compliance

　　COMPETENCIES:

　　Approachability, Customer Focus, Drive for Results, Managing Through Systems, Negotiating, Written Communication, Decision Quality, Developing Direct Reports, Managing Diversity, Learning on the Fly, Managerial Courage, Organizing, Priority Setting, Problem Solving

　　RELATIONSHIPS WITH OTHERS:

　　Interacts on a daily basis with Manufacturing, Quality Assurance, Engineering, Planning, Regulatory Affairs, and R&D

　　WORKING CONDITIONS:

　　80% Office environment which includes sitting for long periods of time and computer use.

　　20% Manufacturing environment exposure to temperature, noise, chemical or potent compound exposure.

　　DISCLAIMER:

　　The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.

　　Mallinckrodt is a global specialty p harmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing.

　　To learn more about Mallinckrodt, visit www.mallinckrodt.com.

　　Mallinckrodt Pharmaceuticals (“the Company”) maintains a continuing policy of non-discrimination in employment. The Company is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, religious creed (including religious dress and grooming practices), disability (mental and physical), marital status, medical condition, genetic information, military and veteran status, national origin (including language use restrictions), political activities or affiliation, race, sex (including pregnancy, child birth, breastfeeding and medical conditions related to pregnancy, child birth or breastfeeding), gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law. Furthermore, it is our policy to provide equal opportunity to individuals with disabilities and protected veterans in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations on every location in which the company has facilities. This policy of non-discrimination shall include, but not be limited to, the following employment decisions and practices: recruiting, hiring; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising.

　　Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e. Open Payments) and certain state laws.