Process Development Sr Scientist

Inteldot•Juncos, PR

1d•Onsite

About The Position

Inteldot has over 15 years in the life science industry with allocations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico. Administrative Shift - Able to work different shift and on weekend during characterization or validation. To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor.

Requirements

Experience supporting sterile drug product manufacturing within the pharmaceutical or biotechnology industry.
Validation experience in highly regulated industry.
If possible, filling validation and work on technical documentation.
Experience authoring and executing validation protocols, characterization studies, technical reports, investigations, and change controls.
Strong knowledge of GMP requirements, aseptic processing principles, contamination control strategy, and pharmaceutical quality systems.
Ability to analyze manufacturing data, identify process trends, and recommend scientifically sound solutions.
Experience working in cross-functional teams with Manufacturing, Quality, Engineering, Regulatory, and Technical Services.
Strong technical writing, communication, presentation, and project management skills.
Proficiency with Microsoft Office (Excel, Word, and PowerPoint) is required.
Fully bilingual (English/Spanish).
Science background as Engineering or microbiology

Responsibilities

Designs, monitors, or conducts strategies with general guidance from the supervisor.
Provides data analysis and interpretation and assesses the impact of the data on the project.
Keeps current in technical expertise and areas relevant to their function.
Monitors field of expertise, including literature and technology development, and communicates relevant observations.
Develop and implement new and novel protocols to address specific issues.
May represent the department on project teams under the supervision of a senior scientific staff member.
May initiate productive collaborations within and outside of the department or company.
Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies.
Able to develop solutions to routine technical problems of limited scope.
Comprehensive understanding of validation protocol execution requirements.
In-depth knowledge of validation processes as applied to new equipment installations.