Are you Covidien?
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2011 revenue of $11.6 billion, Covidien has 41,000 employees worldwide in more than 65 countries, and its products are sold in over 140 countries. Please visit http://www.covidien.com to learn more about our business.
Founded as Mallinckrodt in 1867, the $2 billion Covidien pharmaceutical segment is in the process of spinning off into a separate business. This creates exciting opportunities to grow your career within an established organization that is soon to be an independent public company. Currently, the Company expects that the spinoff process will be completed in mid-2013. While we are undergoing the process, the pharmaceuticals business remains a segment of Covidien, and will continue to operate according to the Company’s strategic plan, focusing on our customers and patients who rely on our products. Equally important, pharmaceuticals’ mission remains the same: To make diagnostics and medicines better and safer for you and your family.
We are an affirmative action/equal opportunity employer.
SUMMARY OF POSITION :
Authors, executes, and summarizes validation protocols. Coordinates and manages validation project execution for equipment, critical utility, and computer related systems. Ensures protocols, records, and procedures are in compliance with current Good Manufacturing Practices (cGMP) and approved SOPs. Support investigations for critical equipment, processes, and utilities.
ESSENTIAL FUNCTIONS :
Coordinate and execute validation studies, writing protocols, documenting results, and, generate final reports, and summaries of work for release of equipment tested.
Develops and revises new or existing procedures to insure compliance to cGMP, GLP, and FDA regulations.
Provides technical advice on new equipment and modification to existing equipment to ensure validation/qualification status is maintained in a state of control.
Provides technical assistance and training for personnel.
Recommends changes in policies and procedures, to management, to enhance the company's ability to conform to and maintain compliance with site, corporate and regulatory standards.
Notifies and recommends to management course of action when critical instruments, systems or processes are found to be out of specifications.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS :
Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately.
Other duties as assigned with or without accommodation.
MINIMUM REQUIREMENTS :
Education required/ preferred:
BS degree in engineering/life sciences or equivalent validation experience.
2-5 years of validation experience in a pharmaceutical environment.
Working knowledge of cGMP, GLP, and FDA regulations. Knowledge of typical pharmaceutical equipment.
Ability to read, analyze, and interpret Validation protocols, SOPs, technical procedures, or governmental regulations.
Ability to write protocols, reports, business correspondences and procedures. All communication must be in English, using good grammar and appropriate vocabulary.
Ability to comprehend and apply principles of calculus, modern algebra, and advanced statistical theory.
Ability to define problems, collect data, establish facts, and draw valid conclusions from these observations.
Computer Skills: Ability to utilize MS Office (Word, Excel, Powerpoint, Access), Databases, Must have a working knowledge of the fundamentals of steam sterilization, cleaning validation, and equipment qualification.
Candidate should possess experience in laboratory systems, particularly those with computer controlled functions, and cleaning and sterilization process validation.
Self-motivated, energetic, enthusiastic, and team oriented.
Requires the ability to apply analytical and scientific principles for solving problems and for properly designing validation test cases.
Must have a demonstrated comprehension of high level mathematics (i.e., calculus and/or statistics), and technical writing.
Candidate must have excellent computer software usage skills including, but not limited to MS Word, MS Excel, and MS Access.
Must have excellent knowledge of mechanical equipment engineering and software functional testing
Candidate must possess personal drive and the ability to schedule work assignments so that they are concluded in a timely, complete, and error-free manner with the highest level of accountability
Effective communication with both team members and other plant support groups.
ORGANIZATIONAL RELATIONSHIPS/SCOPE :
Position reports to Validation Manager.
Assumes responsibility for resolving problem situations at the highest level, involving management as necessary.
Responsible for making routine project validation decisions and informing validation and Plant management of developments as they occur.
Possesses deepest sense of personal responsibility in order to provide support to both internal and external customers. Interaction with corporate R&D, and site manufacturing personnel as well as external regulatory inspectors where appropriate.
Assumes responsibility for project deliverables.
Overtime and alternate hours may be assigned in order to meet deadlines and provide support during heavy validation periods.
Performs work in all environments throughout the plant.
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.
As a global healthcare leader, we drive advances in medical devices and medical supplies. Thanks to our scale, scope and pioneering spirit,...