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Process Engineer

3+ years
Not Disclosed
10 Dec. 23, 2024
Job Description
Job Type: Full Time Education: B.E./B.Sc./M.Sc. Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Process Engineer

Location: [Location not specified]
Job Level: Senior Associate
Department: Engineering


Why Patients Need You:

Pfizer’s engineering team plays a crucial role in ensuring patients have access to the medicines they need, when they need them. Whether involved in the design, development, or maintenance of manufacturing processes, engineering is key to improving product availability and efficiency. As part of this innovative team, you will contribute to getting medicines to the world faster, turning possibilities into action.


What You Will Achieve:

As a Senior Process Engineer, you will work with Pfizer’s engineering team to develop and modify process formulations, methods, and controls to meet strict quality standards. Your role will focus on ensuring the robustness of transferred processes and analytical methods in the New Product Introduction (NPI) phase. By recommending and implementing improvements and troubleshooting issues, you will contribute to the success of the manufacturing campaign. Your contributions will help Pfizer meet production goals while maintaining cost and schedule efficiency.


Position Summary:

The Senior Process Engineer is part of the New Product Introduction (NPI) team and will lead product manufacturing campaigns from start to finish. This includes providing technical supervision on quality and EHS (Environmental, Health, and Safety) aspects until the material is released. You will collaborate with various stakeholders to ensure successful transfer and completion of NPI technical transfer projects, with risks minimized to an acceptable level.


Position Responsibilities:

Process Engineering:

  • Develop Manufacturing / Operating Instructions and Standard Operating Procedures (SOPs).

  • Develop, maintain, and troubleshoot process control system recipes/models.

  • Conduct technical assessments to evaluate manufacturing processes.

  • Investigate, report, and troubleshoot quality and EHS-related issues observed during manufacturing or batch record review.

  • Develop, implement, and monitor preventive measures for processing issues.

  • Ensure compliance with site safety and quality standards.

  • Proactively identify and implement process and equipment improvements.

  • Regularly communicate process updates to plant personnel.

  • Provide training to process technicians on processes and procedures.

  • Take ownership of one or more equipment/GMP systems in production and provide system overview with evidence of compliance to internal and external auditors.

Organizational Relationships:

  • Internal: Engineering, Process, Technical Services, Quality Operations teams.

  • External: Subject Matter Experts from sending sites.


Qualifications:

Must-Have:

  • Degree in Engineering (preferably Chemical Engineering) or a science-related degree with a major in Chemistry.

  • 3+ years of experience in a relevant manufacturing environment.

Core Competencies:

  • Strong process engineering and technical knowledge.

  • A results-driven attitude with a strong sense of commitment and urgency.

  • Excellent interpersonal and communication skills, both verbal and written.

  • Ability to adapt and work across different cultures and teams.

  • Strong team player with a versatile skill set.


Pfizer’s Commitment:

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction where it operates.


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