Design Control Engineer III

Pfizer • Andover, MA

5d • Onsite

About The Position

This position will be part of BTx Pharmaceutical Research & Development located in St.Louis, 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.

Requirements

• 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, ISO 14971, 21 CFR 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 Haves

• 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.

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.

Benefits

• this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary.
• We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees