Job Title

Sr Validation Eng

Requisition

JR000013123 Sr Validation Eng (Open)

Location

Hobart, NY (Pharma) - USA036

Additional Locations

Hobart, NY

Job Description

Summary of Position

Implement and execute validation projects ranging from New Product Development, Equipment Validation, Process Validation, Packaging Validation and Cleaning Validation. Coordinate with cross functional resources in the execution of validation projects and ensure compliance with FDA, cGMP and any other appropriate regulations. Support manufacturing and packaging with new product introductions, process improvements, review and approval of Change Control documentation, review triages/exceptions related to deviation of manufacturing process, and provide technical support as required. Ensure product quality through robust testing and process monitoring including use of statistical process control techniques, Six Sigma tools and application of related pharmaceutical experience.

Essential Functions

Develop protocols using engineering experience and statistical process controls. Assist with multiple cross functional projects from development through release to production. Projects include new facilities startup, packaging line FAT and qualifications, and new product launch. Execute activities in support of the Validation Department priorities with the assistance of the department manager. Technical assistance during investigations of process/product issues. Support validation deviations of process/product or equipment. Execute validations as needed, including assisting in product sampling, auditing and technical review functions as defined in study protocols. Strong communication skills. Prepare and maintain validation records in accordance with department procedures to ensure compliance with current standards.

Minimum Requirements

Education:

BS in engineering discipline or technical field related to pharmaceutical manufacturing

Experience:

2-5 years of applied technical experience preferably with validation experience in pharmaceutical manufacturing and packaging.

Preferred Skills/Competencies:

Strong technical and mathematical aptitude. Training or certifications in regulatory and cGMP requirements is desired.

Other Skills/Competencies:

Strong computer literacy—MS office products, statistical analysis (Minitab) and database usage. Knowledge of statistical process controls is also required for equipment qualifications.

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.