R2 Manufacturing Quality Engineer- 12 Hr Night Shift 7p-7a

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

In your role, you have the all-important task of ensuring that quality control procedures adequately evaluate our organization's products. You will be relied on to determine if our current methods and techniques result in meeting the prescribed standards, methods and procedures. You will analyze and design inspection and testing process, develop new analytical methods and techniques to support our quality programs. You will provide statistical analysis, centralized investigation support, technology implementation, and establish requirements for the transfer of methodology from R&D. You will ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your dedication and hard work that will make it possible for Pfizer’s customers and patients to receive the medicines they need, when they need them.

• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Assure that the resources are appropriately designated on the Finishing lines to ensure proper coverage and execution of activities in accordance with current Good Manufacturing Practices {part of GxP} compliance.
• Monitor aseptic core to ensure continual compliance with cGMP and facility construction/maintenance requirements and perform evaluations on personnel in the aseptic core.
• Provide real time quality support for aseptic/microbiological related issues in the aseptic and controlled areas.
• Provide support for the Quality Control laboratories, Biological Quality, Chemical Quality, and Incoming Material Quality in the management of master data configuration, data migration, and reporting design.
• Perform reviews and evaluate sensitive, confidential information and develop recommendations for use by the plant quality assurance department.
• Conduct Microbiological and Sanitization evaluations on an as needed basis.
• Implement process improvements and provide corrective actions with a focus on quality processes.
• Work closely with manufacturing and other support functions to troubleshoot during unexpected events.
• Direct manufacturing staff to uphold quality and determine when manufacturing operations must halt to properly investigate production issues.
• Organize data from multiple sources, extracting key information and writing reports and summaries.
• Perform impact risk assessment as well as assist in root cause determination.

• BA/BS required (Science degree preferred).
• 0-2 years previous pharma experience preferred.
• Exceptional interpersonal skills and proven track record of teamwork, adaptability, innovation and initiative required.
• Experience in a clean room environment desirable.
• Strong oral/written communications skills and leadership skills required.
• Ability to work well with all levels of personnel throughout the facility.
• Capable of rapidly absorbing technical data and ability to apply this knowledge to a pharmaceutical manufacturing environment.
• Available to work off-shifts and/or weekends.

• Experience at a manufacturing site
• Experience of writing and managing deviations
• Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management

PHYSICAL/MENTAL REQUIREMENTS

• Stand up to 8 to 10 hours
• Sit up to 2 to 4 hours
• Occasionally lift a maximum of 20 pounds 3 times per shift
• Walking and climbing stairs
• Work around and close to moving equipment

NON-STANDARD WORK SCHEDULE

• Ability to work overtime as required supporting business needs.
• Ability to gown aseptically for entry into the Aseptic core areas.
• Ability to follow area specific gowning requirements for entry in to the Terminally Sterilized areas and/or other classified solutions/filling areas.

Relocation support available

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.

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.