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Lead Process Engineer

2 months ago

Coventry, United States Germer International Full time
Position Overview


As a key member of the Manufacturing Technology Team at Germer International, the Lead Process Engineer is tasked with the design, installation, and implementation of processes and equipment that facilitate the GMP production of small molecule active pharmaceutical ingredients (APIs) in a safe, compliant, and efficient manner.

Key Responsibilities


The Lead Process Engineer will leverage a comprehensive set of skills in safety, environmental compliance, GMP, engineering, leadership, and technical expertise to address a variety of challenges.


Essential duties include:

  • Facilitating the technical transfer of new processes from initial concept to final product delivery.
  • Assessing the scale and equipment compatibility of new processes within the current facility.
  • Designing and implementing new equipment or modifying existing systems to meet new process specifications.
  • Overseeing process safety measures with a focus on PSM implementation in accordance with established procedures.
  • Conducting qualification and validation activities aligned with the site master plan.
  • Creating project documentation and providing training to relevant personnel.
  • Assisting with project management tasks as necessary.
  • Utilizing engineering knowledge to support the execution of capital and operational projects at the site.
  • Offering technical assistance to various functional groups within the organization, particularly during production to resolve issues and ensure compliance with process protocols.
  • Managing change controls, quality events, and CAPA within the quality management system to support ongoing production.
  • Participating in safety meetings and addressing engineering-related action items.
  • Administering the engineering document repository.
Qualifications


The ideal candidate will possess a Bachelor of Science degree in Chemical Engineering or a closely related discipline, with a minimum of 7 years of relevant experience. Candidates with a background in manufacturing, engineering, or project management related to pharmaceutical ingredients, specialty, or fine chemicals are preferred.


Additional qualifications include:

  • Experience in batch manufacturing across a diverse range of unit operations and equipment.
  • Familiarity with cGMP manufacturing practices.
  • Experience in both project engineering and process engineering.
  • Knowledge of cGMP and FDA regulations.
  • Understanding of OSHA Process Safety Management Standards and other pertinent regulations.