Sr. Validation Engineer
Location:
Sanford , North Carolina
Posted:
November 22, 2017
Reference:
272258409

ROLE SUMMARY The position will provide process validation, cleaning validation and troubleshooting support for all equipment/unit operations and processes on site related to bacterial fermentation, purification of polysaccharides and proteins activation, and conjugation of vaccine drug substances. The position leads and/or participates in the planning, preparation and execution of process and cleaning validations, including continued process verification, as well as supporting tech transfer activities and related projects. This includes generation of protocols and cleaning assessments, direct sampling of equipment, working with manufacturing to align sample schedules, understanding Delta V controls, and pulling data from LIMs. In addition, the incumbent must be able to think through issues and troubleshoot problems related to cleaning and processing, work with the investigations group to provide technical justifications, understanding changes to cleaning and process systems, and interact with regulatory authorities during audits. The incumbent will be expected to develop overall validation strategies for specific projects. At a minimum, the person should be able to execute work independently, work with various groups across the organization, be a self-starter, and be able to oversee and lead projects to ensure that the cleaning and/or process is running as intended, that the cleaning/process is appropriately validated and runs continuously in a validated state, and look to identify continuous improvement opportunities. In addition, knowledge of electronic systems including PDOC's, LIMS, SAP, MS Word and MS Excel will be required as part of the job. The person should be highly motivated, a self-starter, and be able to work with a team on projects as well as on their own. ROLE RESPONSIBILITIES Responsibilities include the following: 1. Process and cleaning validation activities, including continued process verification related to the technology transfer of new products as well as updates/optimizations to existing commercial products. Activities include a. Defining PV/CV strategies b. Generating and executing protocols and writing final reports c. Sampling d. Generating of regulatory submission documents e. Project management of overall and individual PV/CV projects and activities 2. Write impact assessments for investigations. 3. Perform and lead gap analyses and risk assessments for tech transfers 4. Write justifications for the assessment of change controls for process impact. 5. Ability to manage multiple projects and activities of moderate complexity simultaneously. 6. Liaise with site functions such as Manufacturing, Planning, QA, QC, Operations, and Regulatory Affairs as well as off-site functions such as PharmSci and Research and Development. 7. Support regulatory inspections through the preparation, defense and interaction with auditors in areas related to process and cleaning validation. 8. Provide expertise for trouble-shooting and resolution of process and cleaning issues. 9. Work to implement a culture of Right-First Time and continuous improvement relative to cleaning and process procedures and systems. 10. Provide Technical Support to Manufacturing, QA, QC, etc. The position requires execution and management of multiple projects at the same time and good communication skills to keep customers, peers, area management and site leadership up-to-date with progress of all projects in order to ensure validations are completed in a timely manner and on schedule. QUALIFICATIONS Grade 10: A minimum of a BS degree + 7 years of experience; MS + 4 years of experience; PhD degree + 0-4 years of experience in any of the following disciplines: Chemistry, Biochemistry, Biotechnology, Chemical Engineering, Chemistry, or equivalent science related or engineering discipline. Direct knowledge and experience in process and/or cleaning validation within a biopharmaceutical/pharmaceutical cGMP environment is desired. Experience with FDA and EU licensing and inspection, experience with technology transfer and project management is also required. Additional experience in other areas of validation is a plus. PHYSICAL/MENTAL REQUIREMENTS Position requirements are typical for an office-based work environment. There are no unusual physical or mental requirements for this position. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Schedule is primarily day shift but may require off-shift work on occasions. The position may require working on the floor in manufacturing at times which will require a heightened safety awareness and aseptic gowning will be required. 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. Last Date to Apply for Job: 24 November, 2017 This job is (Pfizer) (Exempt) (US/PR) Grade: 010 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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