Design Control Engineer III

ROLE SUMMARY

This position will be part of BTx Pharmaceutical Research & Development located in MO or Andover MA. The incumbent will lead design control projects for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle. They will interact with cross functional development teams working with all levels of employees.

ROLE RESPONSIBILITIES

• Ensures that combination product development activities are compliant with quality and regulatory standards both internal and external.

• Lead design control and risk management activities for combination product development programs ensuring deliverables are appropriately authored approved and maintained to support clinical trials and commercial licensures.

• Provide input and support for design validation including but not limited to human factors engineering assessments.

• Support the generation of all regulatory submission data and content for assigned device projects.

• Support the assessment of external design companies and suppliers for capability of quality systems facilities and procedures to support device development and supply.

• Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture.

• Support internal and external audits of the DPDD Quality System.

QUALIFICATIONS

Must Have

• BS degree in appropriate Science & Engineering discipline (Chemistry Biochemistry; Biomedical Mechanical Materials Chemical Engineering; or other related discipline) with a minimum of 6 to 8 years of relevant experience in the Pharmaceutical Combination Product and/or Device industries.

OR

• MS degree in appropriate Science & Engineering discipline (Chemistry Biochemistry; Biomedical Mechanical Materials Chemical Engineering; or other related discipline) with a minimum of 4 to 6 years of relevant experience in the Pharmaceutical Combination Product and/or Device industries.

• Thorough working knowledge of ISO 9001 ISO 13485 ISOCFR 820 ISO 11040 and the EU Medical Devices Directive.

• Working knowledge of EN 62366 and EU Medical Devices Regulation.

• Capable of working independently with minimal supervision

• High level of attention to technical details and accuracy.

• Able to prioritize multiple responsibilities and to work on multiple tasks simultaneously.

• Able to work collaboratively in cross functional teams.

• Excellent communication (e.g. oral written presentation) and interpersonal relationship skills.

• Proficiency in general computer software such as word processing spreadsheets presentations.

• Understand Good Manufacturing Practices (GMP)

Nice To Have

• Knowledge of current US and global Regulations FDA and ICH guidance ISO standards for syringes/injectors luer connectors and quality system regulations (Part 4) for combination products

• Experience in Design Controls for Combinations Products

• Device Risk Management expertise

• Understand statistical sampling plan and statistical analysis of test results.

• Familiar with Human Factors Engineering - Usability Engineering.

• Understand project management methodologies and capable to provide technical leadership for projects.

• Familiar with device assembling manufacturing process

• Ability to perform mathematical calculations and ability to perform complex data analysis.

Other Job Details

• Work Location Assignment:On Premise

Relocation assistance may be available based on business needs and/or eligibility.

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. This position requires permanent work authorization in the United States.

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