Pfizer Associate Validation Specialist in United States
This position is for an individual contributor to the Quality Operations Validation department.
The successful candidate will assist in validation of equipment; assist in the development of sterilization/cleaning cycles for new processes or equipment; performs testing and documents results for review by site, corporate and governmental review; pursues increased familiarity with equipment in order to authoritatively explain their function and design.
-Assists with development of validation protocols, performs testing and writes validation reports for various equipment. Generates validation protocols using templates. Primary responsible for protocol execution of various types of basic processing equipment under the direction of Validation Manager.
-Issues data, memos and reports concerning above projects.
-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.
-Performs special projects as assigned by department manager.
-Adheres to all company and GMP procedures, along with safety regulations within the plant.
-Assists with validation activities performed by outside validation companies; assures that department and company policies are adhered to.
-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.
- BS in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science and 0 to 3 years related experience and/or training; or equivalent combination of education and experience.
Knowledge of cGMP and internal SOPs and general knowledge of associated industry and regulatory guidance documents.
Sound working knowledge of the operation of various pharmaceutical processing equipment, labeling/packaging equipment 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; able to readily identify/report deviations to management in a timely manner.
To perform this job successfully, an individual should have working 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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- 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. If necessary travel to other locations.
- Relocation eligible upon management approval
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.
The job is open only to Protected Individuals (as defined by 8 U.S.C. § 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents ("green card holders"), Refugees and Asylees.
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.
Last Date to Apply for Job: May 24, 2018
Eligible for Relocation Package
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.