Engineer Senior
Apply NowCompany: ACL Digital
Location: Cambridge, MA 02139
Description:
Client Cambridge MA (AMA)- Sr Engineer L5
standard business hours
The Senior Engineer works as part of a multi-disciplinary program team to build drug delivery solutions which meet user requirements for Client's portfolio of therapeutic products from concept through commercial entry. The individual advances technical programs, contributing to definition of design requirements, identification and realization of technical solutions, authoring of test methods and reports, and authoring of technical analyses to advance programs. The successful candidate establishes well-supported insights for development, clinical and commercial stage solutions to serve user needs and the needs of the pipeline portfolio, using a range of program tools, design characterization and verification methods, and design reviews. S/he ensures that the required performance and quality targets are satisfied and helps identify and reduce technical risks on the program.
Responsibilities include but are not limited to:
a) support/ lead process development and commercialization of gas sterilization processes of combination products
b) coordinate/ lead manufacturing site requirements to support sterilization requirements
c) support the design control process and qualification of primary components
d) support/ lead tech transfer projects for combination products
e) support/ lead the development and operational improvements with key primary component suppliers
g) support development of characterization methods for mechanical and physical properties of primary components
h) support on-going deviation/ CAPA and change control
i) support/ lead Client supplier/ raw materials sterility assurance assessments
j) collaborate extensively with internal and external stakeholders i.e. manufacturing, suppliers, quality, regulatory, senior management, etc.
k) drive and influence key opinion leaders by providing technical papers, presentations and attending key conferences
Preferred Qualifications
a) 3+ years in ethylene oxide or other gas sterilization processes
b) 3+ years industry experience in sterility assurance of combination products
c) 3+ years in ethylene oxide, moist heat, and/ or vaporized hydrogen peroxide sterilization
d) Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
e) Strong problem-solving skills
f) Capability to advance multiple projects in a fast paced environment
g) Strong oral and written communication skills, decision making, presentation, and organization skills
standard business hours
The Senior Engineer works as part of a multi-disciplinary program team to build drug delivery solutions which meet user requirements for Client's portfolio of therapeutic products from concept through commercial entry. The individual advances technical programs, contributing to definition of design requirements, identification and realization of technical solutions, authoring of test methods and reports, and authoring of technical analyses to advance programs. The successful candidate establishes well-supported insights for development, clinical and commercial stage solutions to serve user needs and the needs of the pipeline portfolio, using a range of program tools, design characterization and verification methods, and design reviews. S/he ensures that the required performance and quality targets are satisfied and helps identify and reduce technical risks on the program.
Responsibilities include but are not limited to:
a) support/ lead process development and commercialization of gas sterilization processes of combination products
b) coordinate/ lead manufacturing site requirements to support sterilization requirements
c) support the design control process and qualification of primary components
d) support/ lead tech transfer projects for combination products
e) support/ lead the development and operational improvements with key primary component suppliers
g) support development of characterization methods for mechanical and physical properties of primary components
h) support on-going deviation/ CAPA and change control
i) support/ lead Client supplier/ raw materials sterility assurance assessments
j) collaborate extensively with internal and external stakeholders i.e. manufacturing, suppliers, quality, regulatory, senior management, etc.
k) drive and influence key opinion leaders by providing technical papers, presentations and attending key conferences
Preferred Qualifications
a) 3+ years in ethylene oxide or other gas sterilization processes
b) 3+ years industry experience in sterility assurance of combination products
c) 3+ years in ethylene oxide, moist heat, and/ or vaporized hydrogen peroxide sterilization
d) Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
e) Strong problem-solving skills
f) Capability to advance multiple projects in a fast paced environment
g) Strong oral and written communication skills, decision making, presentation, and organization skills