Process Engineer I

Job Overview:
We are seeking a highly skilled and motivated Process Engineer to join our dynamic team As a Process Engineer, you will be responsible for designing, implementing, and optimizing manufacturing processes to ensure efficient production of high-quality pharmaceutical products. You will work closely with cross-functional teams to ensure compliance with industry standards, regulatory requirements, and company objectives.

Key Responsibilities:

• Process Design & Optimization:

  • Develop, implement, and optimize manufacturing processes for the production of pharmaceutical products.
  • Conduct process simulations and troubleshoot issues to ensure smooth production flow.
  • Identify and implement continuous improvement initiatives to enhance process efficiency, yield, and quality.

• Process Validation & Qualification:

  • Lead process validation and qualification efforts in accordance with regulatory guidelines and company standards.
  • Create and execute protocols for process validation and ensure thorough documentation.
  • Ensure that all processes comply with FDA, EMA, and other relevant regulatory requirements.

• Troubleshooting & Technical Support:

  • Provide technical support to manufacturing teams to resolve process-related issues.
  • Monitor key process parameters and make adjustments as necessary to maintain optimal performance.
  • Lead investigations into process deviations and implement corrective and preventive actions.

• Collaboration & Cross-Functional Support:

  • Work closely with R&D, Quality Assurance, and Manufacturing teams to develop new products and enhance existing ones.
  • Provide engineering expertise and support during the technology transfer process from development to manufacturing.
  • Collaborate with the validation and regulatory teams to ensure compliance with regulatory submissions and audits.

• Documentation & Reporting:

  • Prepare and maintain detailed documentation, including process flow diagrams, standard operating procedures (SOPs), and process control plans.
  • Generate and analyze process data to provide insights into performance, improvement opportunities, and cost savings.
  • Assist in preparing regulatory submissions and audits by providing necessary process documentation.

Qualifications:

• Education & Experience:

  • Bachelor's degree in chemical, Mechanical or Biomedical engineering, Pharmaceutical Sciences, or a related field.
  • At least 2 years of experience in the pharmaceutical industry

• Skills & Competencies:

  • Strong problem-solving and analytical skills.
  • Proficiency in process modeling software and statistical analysis tools.
  • Excellent communication skills, both verbal and written.
  • Ability to work effectively in a team-oriented, fast-paced environment.
  • Detail-oriented with a strong focus on compliance and quality assurance