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Pfizer · 3 weeks ago

Principal Packaging Engineer- Drug Product Design & Development

United States - Missouri - St. Louis - Chesterfield

Full-time

Onsite

Senior Level, Lead/Staff

$103K/yr - $172K/yr

8+ years exp

Pfizer is a leading biopharmaceutical company, and they are seeking a Principal Packaging Engineer for their Biotherapeutics Pharmaceutical Research and Development group. The role involves overseeing laboratory operations, ensuring compliance with standards, and providing strategic direction for project teams while nurturing professional growth among team members.

BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

No H1B

U.S. Citizen Only

Responsibilities

Responsible for overseeing the day-to-day running of the laboratories

Provide supervision of the laboratory resources to meet DPDD objectives

Review testing work instructions, test protocols, lab notebooks and reports

Develop 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 direction

Act as subject matter expert for laboratory operations to ensure effective management and control within the labs to maintain compliance to ISO 13485

Accountable for equipment calibrations / qualifications in accordance with Pfizer’s 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 needs

Interact 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 effectively

Lead 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 maintained

Support 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 processes

Developing goals and contributes to the reviews for the supervised packaging engineers

Qualification

Pharmaceutical Parenteral PackagingISO 13485 ComplianceRegulatory Standards KnowledgeManufacturing PracticesProject Management MethodologiesComputer Software ProficiencyTechnical LeadershipCross-Functional CollaborationCommunication SkillsAttention to Detail

Required

Bachelor's 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 Development

PhD Degree with 8+ years of experience

Knowledge 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 13485

Knowledge of packaging related regulatory standards and guidance

Capable of working independently with minimal supervision

High level of attention to technical details and accuracy

Being able to prioritize multiple responsibilities and to work on multiple tasks simultaneously

Demonstrated ability 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

Knowledge of current US and global Regulations, US/EU/JP Compendia, ISO standards (e.g., ISO 13485, 11040, 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 needed

Understand component selection and device design activities

Possess and exercise breadth of packaging understanding within and outside Pfizer

Understand 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 strategy

Ability to work in a lab and office environment