Senior Process Development Engineer with Security Clearance

Company: Mantel Technologies
Location: Fort Collins
Posted on: March 19, 2020

Job Description:

PositionMantel Technologies is seeking a Senior Process Development Engineer to lead transition and scale-up of a blood product. Participation in other R&D and product scale-up efforts is expected. The Senior Process Engineer is accountable for leading the process design for lyophilized blood product currently under development, will be responsible for setting up new process facility (pilot scale). To be successful in this role, the ideal candidate must have extensive process development expertise in Chemical, Biochemical, or Mechanical Engineering . The incumbent will lead process-related planning and execution laboratory studies, analyzing experimental data, document results, and presenting their findings to technical team members, company leadership and external R&D sponsors. Responsibilities includeWork closely with Mantel Veterinary team and external collaborators to meet production targets in support of various research protocols for austere veterinary medicine solutions under developmentCoordination of process validation activities involving cross-functional, multi-departmental teams including: *Manufacturing (contract), Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.*Support additional R&D initiatives, some of which will be unrelated to blood products and lyophilization Qualifications*BS Chemical, Mechanical or Biochemical Engineering*Minimum 10 years' experience in a regulated product environment*US citizen capable of maintaining a security clearance, active clearance a plus but not required*Strong understanding of biological process validation activities including risk assessments and evaluations*Demonstrated experience writing and executing GMP documentation and Validation protocols such as Installation, Operation, and Performance Qualification documents.*Ability to work in both a regulated product environment and a distributed R&D team*Strong analytical and critical thinking skills*Must have a strong analytical, math, and problem solving skills. *Ability to draft, read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. *Effectively apply math and physical science concepts. *Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Computer Skills: Proficient in the use of MS Office suite of tools as well as G-Suite, as this individual will perform work within these systems on a routine basis. *Excellent Communication skills, both verbal and written*Must be able to organize time in order to successfully manage multiple projects and priorities *Ability to read, understand, interpret and implement technical writing and instructions. *Effective interpersonal relation skills, while maintaining the adaptability to achieve company goals *Verbally expresses ideas and facts in a clear, logical, concise and in accepted grammatical style.*Background investigation required; E-verify employer Preferred:MS degreeExperience with blood products and freeze drying processes About MantelMantel is focused on solving emerging and urgent capability gaps through technology development and SME-level technical services. We aim to create and maintain a collaborative, innovative, and purposeful work environment built in conjunction with our cultural imperatives of a positive work/life balance and making positive contributions to the world we live in. Mantel offers a competitive benefits package including paid time off, holiday, 401k, health insurance, quality of life benefits, and a bonus compensation program. Mantel is an Equal Opportunity Employer and supports diversity in the workplace. Applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, veteran status, marital status, sexual orientation, gender identity, or any other characteristic protected by applicable laws. Mantel is an E-Verify employer. E-Verify is an internet-based system operated by the Department of Homeland Security (DHS) in partnership with the Social Security Administration (SSA) that allows participating employers to electronically verify the employment eligibility of their newly hired employees in the United States.

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