SPECIFIC DUTIES, ACTIVITIES, AND RESPONSIBILITIES: 

• Provide direct mechanical support to the New Product Development and Innovation groups for the purpose of developing new formulations, processes and technologies.
• Work with customers on new projects defining equipment and process requirements needed to develop proposed formulations.  
• Define, specify, and order specialized equipment needed to perform development and processing activities relative to project needs.
• Assemble and operate process equipment relative to development projects.
• Assemble and calibrate laboratory equipment and instruments; set up a variety of test samples and run routine tests.
• Collect and reduce experimental data and analyze results of tests using engineering principles and mathematical techniques
• Support/oversee the creation and modification of controlled documentation as it relates to business development projects.
• Support project management technical activities, which will range from product formulation development, clinical trials batch manufacture, process development, validation and BFS manufacturing
• Assist all other support groups to achieve quality manufacturing systems (eg. Validation, Operations, Quality, Regulatory, etc.).
• Other duties as assigned.

 

POSITION REQUIREMENTS

Education and Experience:  

• Bachelor of Science in Chemical Engineering
• BS in Chemistry or science discipline with required experience.
• 5 years relevant experience in a pharmaceutical manufacturing environment with demonstrated “hands on” experience.

Knowledge/Skills Requirements 

• High level of attention to detail.
• Excellent documentation skills.
• Strong Mechanical aptitude.
• Strong communication skills both written and oral.
• A full complement of computer literacy skills (e.g., word processing, spreadsheets, database software, AutoCAD etc.) is preferred.
• Strong problem solving and analytical skills.
• Detailed knowledge of CIP/SIP process, aseptic processing, sterile filtration, bulk sterilization and formulation of aqueous, emulsion and suspension products
• Knowledge of alternative methods of sterilization including dry heat, VHP, ethylene oxide and gamma irradiation
• Must be proficient in reading and understanding P&IDs, floorplans and other engineering schematics
• Must be familiar with the use of standard utilities used in pharmaceutical processing including: pure steam, compressed gases, hot WFI, closed loop cooling water and various electrical supplies
• Must have a working knowledge of process control and be able to assist/supervise the construction of process setups.
• Ability to work independently on multiple projects.
• Works well in a team environment.
• Must have hands on experience in BFS machine setup and operation.
• Well organized and detail and multi-task oriented.
• Works well under pressure and able to prioritize workloads.
• Must be able to interact effectively with a variety of individuals and personalities within and between departments.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Perform independent work related to projects and/or routine activities.
• Review reports, etc. for accuracy and logic.
• Meet deadlines and work under pressure with limited supervision.
• Must be able to perform risk assessments in a timely manner and act accordingly.
• Should be familiar with cGMP and safe work practices.
• Ability to read, comprehend, execute and communicate English written SOP’s.
• Be organized.  Maintain good records, and be able to access them rapidly.  Understand where information can be found.
• Be knowledgeable.  Bring experience to the organization.  Learn new skills; collect new information.  Demonstrate a willingness to share skills and information with others.
• Make sound judgments.  Blend knowledge and analysis with logic, active listening, and a continuing interest in simplification.  Act ethically.
• Demonstrate a bias toward action.  Get things done.  Be willing to take a position, and assert influence to drive improvement.  Foster teamwork to get results.
• Demonstrate initiative.  Develop ideas, and collect them from others.  Continuously seek opportunity. Must be detail oriented.  Clarify issues, investigate.

EEO:

Catalent Pharma Solutions offers a competitive compensation, paid time off and benefits package including 401K and tuition reimbursement. Successful candidates must pass a background check and drug screen. We are an Equal Opportunity Employer M/F/D/V Our equal opportunity policies and affirmative action programs are designed to ensure that all applicants and employees are considered for opportunities without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, veteran status or disability except where an accommodation is unavailable and an individual’s disability is a bona fide occupational disqualification. These policies and programs cover every aspect of the employment experience: recruitment, selection, promotion, transfer, layoff, recall from layoff, compensation, access to training, benefits, education, tuition assistance, company-sponsored social and recreational activities, and termination.