Principal Packaging Engineer- Drug Product Design & Development at Pfizer

This position is in the Biotherapeutics Pharmaceutical Research and Development Drug Product Design & Development group located in Chesterfield MO and Andover MA. The position requires collaborating with the Quality & Compliance organization to champion quality in lab operations to ensure compliance with standards and supports manager forums and new hire onboarding activities. Responsibilities include supplying packaging deliverables and support required for new drug product development authoring required regulatory submission sections addressing packaging/component related queries and contributing to the transfer of new drug products to commercial manufacturing sites.In addition to these responsibilities this role includes providing strategic direction for project teams nurturing professional growth for team members and ensuring accountability to drive successful execution across leader will foster a culture of continuous improvement and drive initiatives to enhance operational efficiency. The incumbent will be responsible for delivering the following activities associated with component and container closure system selection qualification development as well as design control packaging engineer deliverables for medical devices and combination products (MDCP). These activities include:Work on and supervise lab activities related to testing and investigation of MDCPs.Act as a Subject matter expert for laboratory operations to effectively manage the labs and to maintain compliance to ISO 13485Accountable for equipment calibration/qualification in accordance with Pfizers Quality Management System.Support electronic lab notebook super user and is accountable for the compliance of the lab notebooks in the department procedures and best practiceDevelop and manage technical development needs of junior staff as appropriateAssists project and group leads in developing goals and contributes to the reviews for other packaging engineers.Position ResponsibilitiesResponsible for overseeing the day-to-day running of the laboratoriesProvide supervision of the laboratory resources to meet DPDD objectives .Review testing work instructions test protocols lab notebooks and reportsDevelop and expand the technical expertise and skills of the team to ensure SMEs have the right skills knowledge and tools to keep up with DPDD requirements and directionAct as subject matter expert for laboratory operations to ensure effective management and control within the labs to maintain compliance to ISO 13485Accountable for equipment calibrations / qualifications in accordance with Pfizers Quality Management System.Optimize processes implement initiatives and strategies to improve processes to maximize the quality and efficiency in support of Design Control projects.Implement a collaborative relationship between all DPDD business functions to provide effective support and input package engineering technical knowledge for project needsInteract with and engage with multiple business functions e.g MT EHS Facilities Quality and Global Workplace Solutions (GWS) on a regular basis to ensure alignment understand trends and resolve issues effectivelyLead and manage cross-functional project teams aimed at harmonizing lab and business processes. Drive process alignment and compliance across functional teams while overseeing a team of direct reports to ensure consistent execution and accountability.Work closely with local and global EHS teams to ensure compliance with all safety processes and protocols is maintainedSupport lab notebook super user and accountable for the compliance of the lab notebooks in the department; Work with eLN superuser for continuous improvement of system and processesDeveloping goals and contributes to the reviews for the supervised packaging engineersOrganizational Relationships:Combination product development teams device development leads human factors SMEs design engineers and device development scientistsCo-development team drug product and device SMEsQuality AssuranceGCMC (Regulatory)PGS manufacturing sites and post launch device teamExternal designers and contract manufacturing organizationsQualificationsBachelors Degree in a appropriate Science & Engineering disciplines e.g. Engineering (Packaging Mechanical Materials Biomedical Chemical etc.) Chemistry Biochemistry; or other related discipline with a minimum of 12 years OR 10 years with a MBA/MS degree with relevant experience with Pharmaceutical Parenteral Packaging DevelopmentPhD Degree with 8 years of experienceKnowledge in parenteral packaging component and component testing equipment e.g. Instron ZebraSci Computrac plunger movement chamber etc.Experience working in a Good Manufacturing Practices (GMP) environment or equivalent e.g. ISO 13485Knowledge of packaging related regulatory standards and guidanceCapable of working independently with minimal supervisionHigh level of attention to technical details and accuracyBeing able to prioritize multiple responsibilities and to work on multiple tasks simultaneouslyDemonstrated ability to work collaboratively in cross functional teamsExcellent communication (e.g. oral written presentation) and interpersonal relationship skillsProficiency in general computer software such as word processing spreadsheets presentationsKey Technical Skills:Knowledge of current US and global Regulations US/EU/JP Compendia ISO standards (e.g. ISO 10993 etc.) quality system regulations (Part 4) for combination products Container Closure Systems for Packaging Human Drugs and Biologics FDA guidance document and other applicable FDA and ICH guidance.Ability to interface with regulatory agencies to provide packaging rationale and justifications as neededUnderstand component selection and device design activitiesPossess and exercise breadth of packaging understanding within and outside PfizerUnderstand project management methodologies and capable of providing technical leadership for projects. Interact constructively with other partner lines and actively shares knowledge and expertise to define packaging strategyPHYSICAL/MENTAL REQUIREMENTSAbility to work in a lab and office environment.NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS Work-related travel will be 5 - 10% of the time (other Pfizer sites vendors conferences etc.).Other Job DetailsRelocation support availableWork Location Assignment:On PremiseThe annual base salary for this position ranges from $102900.00 to $171500.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of lifes moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution paid vacation holiday and personal days paid caregiver/parental and medical leave and health benefits to include medical prescription drug dental and vision coverage. Learn more at Pfizer Candidate Site U.S. Benefits (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa FL or any location outside of the United States.Relocation assistance may be available based on business needs and/or eligibility.Sunshine ActPfizer 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 providers 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 EligibilityPfizer 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. This position requires permanent work authorization in the United States.Pfizer endeavors to make to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing please email. This is to be used solely for accommodation requests with respect to the accessibility of our website online application process and/or interviewing. Requests for any other reason will not be returned.Research and DevelopmentRequired Experience:Staff IC Key Skills Joomla,Banking,C,Market Research,Bpcs Employment Type : Full-Time Experience: years Vacancy: 1 Monthly Salary Salary: 102900 - 171500