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Specialist, Validation


Franklin, OH 45005
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Job Details

Accountable for activities involved in the evaluation, review and approval of the validation master plan, validation protocols and reports and typically includes developing and evaluating quality process and system standards to ensure compliance with Pfizer Quality Standards and governmental regulatory requirements, investigating/troubleshooting validation problems for equipment and/or performance processes, conducting statistical analyses of testing results and process anomalies, and writing, reviewing, approving and/or implementing documentation for new and current validation procedures and technical reports related to equipment, products and/or processes.

+ Project Management - Lead/manage validation projects associated with enhancements of facility, equipment, and product processes

+ Cleaning Validation - development of validation protocols, performs testing and writes validation reports for applicable cleaning processes

+ Computer Software/Automation Validation - development of validation protocols, performs testing and writes validation reports for all computer systems associated with automated equipment and processes are qualified

+ 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 Pfizer 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

+ Additionally, a working knowledge of the operation of various processing/laboratory equipment, for example (but not limited to) the following: cleaning (CIP &COP) equipment, dryers, tanks, filters, washers, sterilizers, depyrogenation oven, HVAC systems, WFI systems, incubators, freezers, vacuum ovens

+ 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)


+ BS in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science and minimum of 5 years related experience

+ Sound working knowledge of cleaning validation, computer software/automation validation, technical product transfer, and product and process validation

+ 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

+ Minimal travel requirements are expected

**EEO & Employment Eligibility**

Pfizer 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. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**Additional Offer Details:**

+ **Last Date to Apply for Job: 11/16/2017**

+ **This job is Pfizer Exempt US Grade: 004**

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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