What are the responsibilities and job description for the Engineer position at ALTEN?
Job Title: Engineer
Location: Onsite at ATO - 3 days onsite - Flexible
Ideal Candidate: 3 years of drug product process development experience in the pharmaceuticals/biotechnology industry. Open to previous job titles with more of a science background. (Ex: Scientist or Engineer previous titles)
Nice to have: Previous Client or pharma experience.
Job Description:
We are seeking a skilled Engineer who can work independently to support technical projects. The ideal candidate will have expertise in drug product fill finish processing, holistic drug product process knowledge, technical transfer, drug product manufacturing, and regulatory filings. Excellent communication skills and proficiency in technical writing are essential for this role.
Key Responsibilities:
Provide technical support for drug product process development, including formulation, filtration, filling (vials/syringes/devices), and lyophilization of parenteral products.
Assist in the development and characterization of drug product processes and the transfer of new technologies to commercial sterile fill/finish sites.
Support process development for commercial drug product processing in areas such as sterile processing, process characterization, tech transfer, and validation.
Collaborate with manufacturing and support functions to provide coordinated support for commercial drug product manufacturing operations and technology transfer.
Participate in global cross-functional teams, working effectively in a highly matrixed team environment to drive efficiency and foster strong relationships.
Troubleshoot issues with drug product processing technologies and equipment, utilizing data-driven analyses and visualizations to determine true root causes.
Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory submissions.
Preferred Qualifications:
Degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry, Biotechnology, or a related field.
3 years of drug product process development experience in the pharmaceuticals/biotechnology industry.
Knowledge of and hands-on experience with end-to-end development for liquid and lyophilized drug products in various presentations.
Experience with unit operations for parenteral manufacturing (e.g., filling, filtration, mixing), specifically lyophilization, is an advantage.
Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes.
Knowledge of protein biochemistry with regard to chemical and physical stability.
Project management skills, including the ability to manage multiple projects and evaluate project resource requirements.
Strong knowledge of drug product manufacturing.
Demonstrated ability to work effectively in cross-functional teams to advance complex projects to completion.
Location: Onsite at ATO - 3 days onsite - Flexible
Ideal Candidate: 3 years of drug product process development experience in the pharmaceuticals/biotechnology industry. Open to previous job titles with more of a science background. (Ex: Scientist or Engineer previous titles)
Nice to have: Previous Client or pharma experience.
Job Description:
We are seeking a skilled Engineer who can work independently to support technical projects. The ideal candidate will have expertise in drug product fill finish processing, holistic drug product process knowledge, technical transfer, drug product manufacturing, and regulatory filings. Excellent communication skills and proficiency in technical writing are essential for this role.
Key Responsibilities:
Provide technical support for drug product process development, including formulation, filtration, filling (vials/syringes/devices), and lyophilization of parenteral products.
Assist in the development and characterization of drug product processes and the transfer of new technologies to commercial sterile fill/finish sites.
Support process development for commercial drug product processing in areas such as sterile processing, process characterization, tech transfer, and validation.
Collaborate with manufacturing and support functions to provide coordinated support for commercial drug product manufacturing operations and technology transfer.
Participate in global cross-functional teams, working effectively in a highly matrixed team environment to drive efficiency and foster strong relationships.
Troubleshoot issues with drug product processing technologies and equipment, utilizing data-driven analyses and visualizations to determine true root causes.
Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory submissions.
Preferred Qualifications:
Degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry, Biotechnology, or a related field.
3 years of drug product process development experience in the pharmaceuticals/biotechnology industry.
Knowledge of and hands-on experience with end-to-end development for liquid and lyophilized drug products in various presentations.
Experience with unit operations for parenteral manufacturing (e.g., filling, filtration, mixing), specifically lyophilization, is an advantage.
Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes.
Knowledge of protein biochemistry with regard to chemical and physical stability.
Project management skills, including the ability to manage multiple projects and evaluate project resource requirements.
Strong knowledge of drug product manufacturing.
Demonstrated ability to work effectively in cross-functional teams to advance complex projects to completion.
