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ECHO Consulting Group

Validation and regulatory documentation for pharma

Process Development Senior Scientist

Bioprocess & BiomanufacturingPosted on Nov 4
ContractJuncos, Puerto RicoNo salary listedIn-person

About the Job

Requirements

  • A doctorate (PhD or PharmD), or a Master’s degree with 3 years of scientific experience, or a Bachelor’s degree with 5 years of scientific experience.
  • Ability to motivate, lead, and/or supervise the activities of others.
  • Ability to develop realistic timelines.
  • Ability to solve problems by applying scientific theory.
  • Ability to independently determine and develop scientific analyses and solutions.
  • Ability to exercise considerable latitude in determining objectives of scientific work.
  • Strong laboratory and project management skills.
  • Ability to develop new hypotheses for scientific experiments.
  • Ability to critically evaluate and interpret results in detail.
  • Knowledge of the scientific relevance of targeted work.
  • Bilingual proficiency in English and Spanish.

Responsibilities

  • Independently monitor or conduct experiments, studies, or series of experiments to advance projects or technologies.
  • Provide advanced data analysis and interpretation, assess the impact of data on the project, and make recommendations.
  • Expand knowledge-seeking beyond the core area of expertise.
  • Identify relevant external competitive knowledge.
  • Independently prepare new and novel protocols and experimental designs.
  • Contribute as a key member of an independent research or project team.
  • Initiate productive collaborations outside the department or company.
  • Introduce new or advanced technologies and concepts.
  • Contribute to scientific journal articles or complex technical documents as lead author.
  • Lead department-wide support efforts such as safety, recruiting, and committees.
  • Develop supervisory and mentoring skills.
  • Make proactive decisions that contribute to achieving milestones.
  • Plan detailed project procedures, including timelines, milestones, methodological approaches, expected results, and necessary resources.

Desired Qualifications

  • Experience supporting sterile drug product manufacturing in the pharmaceutical or biotechnology industry.
  • Hands-on experience with aseptic filling operations, process characterization, process validation (PPQ), technology transfer, and commercial process support.
  • Experience authoring and executing validation protocols, characterization studies, technical reports, investigations, and change controls.
  • Knowledge of GMP requirements, aseptic processing principles, contamination control strategy, and pharmaceutical quality systems.
  • Experience performing statistical analysis using JMP or Minitab and applying data-driven approaches to process optimization.
  • Ability to analyze manufacturing data, identify process trends, and recommend scientifically sound solutions.
  • Experience working cross-functionally with Manufacturing, Quality, Engineering, Regulatory, and Technical Services.
  • Technical writing, communication, presentation, and project management skills.
  • Ability to independently manage multiple projects in a fast-paced manufacturing environment while supporting commercial readiness and continuous process improvement.
  • Experience with single-use technologies, filling equipment, and sterile manufacturing operations.

About the Company

ECHO Consulting Group

Validation and regulatory documentation for pharma

Echo Consulting Group provides specialized validation and regulatory documentation services for the healthcare, pharmaceutical, and biotechnology industries. Its offerings include process, cleaning, equipment, and computer systems validation, paired with regulatory compliance work and audit-ready documentation that meets cGMP and FDA requirements. The firm differentiates itself through long-standing expertise since 2002 and its integration into PharmaLex, which expands access to global resources while keeping its technical focus. Its goal is to help life-sciences organizations achieve regulatory success and efficient validation by delivering reliable documentation and support for validation efforts.

Company size
Not listed
Company stage
Not listed
Total funding
Not listed
Headquarters
Caguas, Puerto Rico
Founded
2002

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