What are the responsibilities and job description for the Process Engineer (Sterilization) position at ACL Digital?
Title : Senior Engineer
Duration : 12 Months
Location : Cambridge MA
Top 3 Must Have Skill Sets :
Sterilization experience
Qualification / quality experience
Commercial process lifecycle management
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 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
