Process Development Engineer II / Lyophilization experience requ

Description Process Development Engineer II: DIRECT HIRE OPPORTUNITY
Every day, Kelly Scientific Resources (KSR) connects scientific professionals with opportunities to advance their careers. We provide clinical research and scientific staffing and placement to pharmaceutical, biotechnology, and medical device organizations across the US.
We currently have a direct hire opportunity for a Process Development Engineer II to join our client's pharmaceutical manufacturing group. Our client is located in Northern Colorado and a leading pharmaceutical research, development, manufacturing and commercial operations company
The Process Development Engineer II will be a key member in the design and implementation of manufacturing processes, instrumentation and equipment from the laboratory through pilot plant and manufacturing scale-up. They will also assist the manufacturing operation in problem solving with regards to equipment and systems, and develops and recommend new process technologies.
Ideal candidate for this position would have a BS degree in Chemical Engineering, Chemistry, or related science field with 3-5 years experience in pharmaceutical manufacturing process scale-up and validation, manufacturing in an Aseptic (sterile) environment; including experience with lyophilizers.
To be immediately considered for this position, click the 'Apply Now!' button. Or, refer a friend by clicking the 'E-mail this job' link provided.
Essential Duties & Responsibilities ' Assist with the planning/selection, design, implementation and validation of specialized equipment for pharmaceutical operations. Equipment includes but is not limited to: steam sterilizers, lyophilizer, syringe and vial fillers. ' Perform and work with formulation development personnel to refine formulations transferred from the Research Groups, while implementing changes to address manufacturability and scale-up. ' Conduct process research, develop product and process optimization procedures. ' Troubleshoot manufacturing problems. ' Provide technical support and technical training to manufacturing personnel. ' Interface with Quality, Regulatory and QC Laboratory groups.. ' Prepare validation protocols and reports, writing of transfer packages, Standard Operating Procedures (SOP's) and regulatory responses.
Education & Experience Requirements ' BS degree in Chemical Engineering, Chemistry, or related scientific discipline with 3+ experience in product and/or process development in the pharmaceutical manufacturing industry to include experience with lyophilizers, manufacturing process scale-up and validation. ' Knowledge of pharmaceutical manufacturing processes and systems in an Aseptic (sterile) environment; including experience with lyophilizers. ' Knowledge of developing data-sets and documentation on formulation process, including setting specifications for transfer into pilot/manufacturing facilities ' Knowledge in Statistical Analysis and spreadsheets. ' Excellent professional written and verbal communication and interpersonal skills. ' Ability to manage multiple projects and prioritize/reprioritize work.
Compensation and Working Conditions Base salary of $ 55-85K, based upon qualifications and experience. This is a full-time position, working Monday to Friday, 8 am to 5 pm with occasional overtime. The company offers a competitive benefits package that includes health, 401K, and paid vacation. A relocation package will be available to a qualified candidate.
To be immediately considered for this position, click the 'Apply Now!' button. Or, refer a friend by clicking the 'E-mail this job' link provided.
'Key words: chemical engineering, chemistry, pharmaceutical manufacturing process scale-up, validation, aseptic manufacturing, lyophilizers
Kelly Scientific Resources® has grown into a $270 million global business as the scientific business unit of Kelly Services. KSR has more than 100 locations in North America, Europe and the Pacific Rim. Please visit us at www.kellyscientific.com to learn more.
Kelly Services is an Equal Opportunity Employer.

Requirements BS degree in Chemical Engineering