About the company
A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
This position is for an individual contributor to the Quality Operations Validation department. Additional responsibilities include but are not limited to: Project Management, Equipment Qualification, Cleaning Validation, Computer Software/Automation Validation, Product and Process Validation.
The successful candidate will provide technical support to managers and professionals in all of the following areas: Quality Assurance, Regulatory, Manufacturing Operations, Deviation Investigations, Asset Improvement and Compliance.
The position requires knowledge of cGMP and associated industry and regulatory guidance documents. The candidate must have demonstrated proficiency in project management skills and must be able to balance multiple priorities.
This position will assist in the development and mentoring of lower level Validation Engineers.
-Project Management - Lead/manage validation projects associated with enhancements of facility, equipment, and product processes.
-Cleaning Validation - supports a team of professionals to ensure that all cleaning processes are qualified and that enhanced products processes are validated appropriately through execution of approved protocols.
-Computer Software/Automation Validation - supports a team of professionals to ensure that all computer systems associated with automated equipment and processes are qualified and that enhanced automated processes are validated appropriately through execution of approved protocols.
-Equipment Qualification - development of validation protocols, performs testing and writes validation reports for various equipment.
-Product and Process Validation - assists/performs product and process validation at the site while following industry contemporary and the company Quality Standards.
-Helps to determine process capability of new equipment through execution of approved protocols and assures defined parameters are incorporated into respective operating procedures and batch records.
-Leads/Performs special projects as assigned by department manager.
-Adheres to all company and GMP procedures, along with safety regulations within the plant.
-Assists with the Site Change Management Program to keep all finished products, equipment, processes and facilities in compliance with contemporary industry standards and regulatory filings.
Provide technical support to managers and professionals in all of the following areas: Quality Assurance, Regulatory, Manufacturing Operations, Deviation Investigations, Asset Improvement and Compliance.
BS/MS or PhD in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science and minimum of 10 years related experience or equivalent combination of education and experience. Previous experience leading a team of individual contributors is preferred.
Sound working knowledge of cleaning validation, computer software/automation validation, technical product transfer, and product and process validation.
Additionally, a working knowledge of the operation of various processing equipment, for example (but not limited to) the following: cleaning (CIP &COP) equipment, washers, sterilizers, depyrogenation oven, fillers, formulation mixing systems, HVAC systems, incubators, freezers, refrigerators, assembly equipment, labeling/packaging equipment, ancillary and integrated inspection equipment.
Ability to read, analyze and interpret common scientific and technical journals; comprehend equipment manuals and translate operational limits into protocols acceptance criteria.
Ability to define problems, collect data, establish facts, and draw valid conclusion; interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract or concrete variables.
To perform this job successfully, an individual should have an advanced knowledge of Microsoft Office (Word, Excel, Outlook, Access, and Projects
While performing the duties of this job, the employee is occasionally exposed to general laboratory and/or manufacturing areas; work near moving mechanical parts; toxic or caustic chemicals; the noise level in the work environment is usually moderate; required to stand; walk; sit; talk or hear; must occasionally lift and /or move up to 25 pounds; specific vision abilities require by this job include ability to adjust focus.
Position requires regular onsite attendance - this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis.
Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements. Must have the ability to work effectively under and manage to strict production, time and performance deadlines. Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment.
This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. •1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. •1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees.
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