SENIOR PROCESS ENGINEER

Job Description

CoreRx, a dynamic pharmaceutical technology company that empowers its employees with responsibility and offers a supportive and highly progressive work environment. At CoreRx you will find a challenging career path directed towards growth and opportunity. We employ talented, motivated people – team players who are innovative thinkers. We offer our employees a comprehensive, competitive program of benefits, and a corporate culture based on core values that include innovation, a results-oriented focus, and ethical behavior.

EXPERIENCE AND EDUCATION REQUIREMENTS

• Must have 8+ years of Pharmaceutical experience, preferably in a process engineering role. Please note, candidates without Pharmaceutical Manufacturing experience will not be considered.
• Solid dose formulations and equipment experience REQUIRED.
• cGMP and validation experience required
• Bachelors degree in Engineering or Sciences

Role and responsibilities

The Senior Process Engineer develops, configures, and optimizes industrial processes from inception through to startup and certification. Assesses processes, takes measures, and interprets data. Designing, running, testing, and upgrading systems and processes.

• Create and execute protocols for Scale-up, Optimization Studies, Process Validation and Cleaning Validation. Develop all documentation for process validations including IQ, OQ, and PQ protocols as well as risk assessments
• Create Manufacturing Batch Records for developmental, clinical, registration and commercial products
• Create/revise existing/new SOP’s for equipment and processes
• Lead/support technology transfer projects. This includes working directly with R&D teams/personnel for the transfer of data, processes and technical specifications for implementation into large scale manufacturing operations
• Analyze data, present/write technical reports and develop design of experiments for new product implementation
• Investigate opportunities for improvement within departments looking specifically to increase accuracy and efficiency. This will encompass workflow evaluations as well as equipment evaluations
• Provide technical assistance/expertise to maintenance and operations personnel on equipment troubleshooting and repairs
• Assist in training Manufacturing personnel
• Author manufacturing deviations and CAPA
• Assist in creation of technical risk assessments
• Perform process capability analysis on production processes
• Implement Lean Manufacturing Principles in Production area
• Assist in gap analysis, FMEA and/or risk assessments to ensure evaluation of critical systems and equipment comply with all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, ISPE, ISO etc.
• Interacts with the regulatory officials to convey the compliance level of the equipment and facility during regulatory inspections
• Strong problem solving, technical writing and statistical analysis skills
• Exhibits strong process and equipment design skills
• Manages projects to deliver results on time and on budget
• Proficient in Process Safety concepts and methodology
• Proficient in Commissioning and Validation strategies and execution
• Focused on Meeting Customer Needs
• Ability to communicate clearly with colleagues and clients in both written and verbal form
• Performs other related duties as assigned by management.

Notification to Agencies:

Please note that CoreRx Inc. does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Master Service Agreement, and specific approval to submit resumes to an approved requisition, CoreRx Inc. will not consider or approve payment regarding recruiter fees or referral compensations.

Job Type: Full-time