Senior Process Engineer

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

RESPONSIBILITIES  

• 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.

WORK EXPERIENCE REQUIREMENTS

• Must have 10+ years Pharmaceutical experience, preferably in a process engineering role.
• Must have experience in solid dose formulations.
• cGMP and validation experience preferred.

EDUCATION REQUIREMENT

• BS degree in Engineering or Sciences.

Senior Scientist

Performs all essential functions of Analytical Chemist III.

• Expected to be the lead scientist for designated projects, to include direct client communications and attendance at project team meetings and teleconferences; ability to make autonomous decisions regarding day to day activities.
• Demonstrates ability to independently manage design/development, optimization, validation and transfer of analytical methods in support of Drug Substances and Drug products.
• Provides analytical services to manufacturing, process development, validation, new material and critical reagent qualifications. All activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, and regulatory requirements.
• Analysis of finished products, in-process materials, raw materials, and cleaning verification/validation samples according to the assigned specifications, methods and protocols. Analytical instrumentation may include, but is not limited to HPLC, GC, TOC Analyzer and Spectrophotometer.
• Demonstrates ability to prioritize assignments; time management and multitasking in a dynamic environment.
• Documents all experiments and results thoroughly with detailed observations.
• Exercises technical discretion in the design, execution and interpretation of experiments that contribute to project strategies and goals.
• Critically assesses experimental data and provides interpretation of results, including statistical analysis.
• Prepares technical reports, summaries and protocols.
• Utilizes independent action and decision making with follow-up reporting to supervision.
• Directs and executes experiments of a scientifically complex nature.
• Demonstrates ability to interact effectively within department team, mentoring and training unit personnel as needed.
• Appreciates and values different perspectives. By example, often motivates co-workers and peers to perform their best work.
• Evidence of effective communication, both verbally and written, highly organized, analytical, accurate, and detail-oriented.
• Demonstrates ability to work successfully in a highly collaborative, team oriented, customer focused environment.
• Responsible for the preparation of robust processes that lead to the development of new technologies that support specific client platforms.
• Provide support for operations and other process support teams by providing scientifically sound recommendations, improving efficiency, meeting of timelines, and the development of successful processes while operating in compliance with cGMP regulations, and company SOPs.
• Performs other related duties as assigned by management.

WORK EXPERIENCE REQUIREMENTS

• Minimum of 5 years’ experience with identification or separation techniques such as HPLC, UPLC, GC, and experience with method development and/or validation

EDUCATION REQUIREMENTS

• Doctorate in scientific field with 3-years’ experience, or MS in scientific field with 5-years’ experience, or BS in scientific field with 10-years’ experience in an analytical environment.

PHYSICAL DEMANDS

• Able to stand, sit for long periods of time.
• Able to read, write, speak and comprehend the English language.

Validation Engineer II

RESPONSIBILITIES

Validation Engineers provide support for validation/qualification initiatives to internal project teams and ensure project schedules are met with an emphasis on building, room, utility, equipment, and computer system validations; ensure that CoreRx systems are in compliance with regulatory requirements; author, assess, maintain, and review validation and qualification lifecycle documentation.Areas of responsibility for the Validation Engineer II include:

• Author validation documentation including user requirements, functional requirements, and design requirements, validation summary reports and test protocols for installation, operation, and performance of facilities, equipment and software.
• Direct and perform the execution of validation protocols.
• Development and modification of Standard Operating Procedures (SOPs) and Forms for equipment and systems.
• Work with third-party suppliers, subcontractors, and customers on validation projects.
• Aid in the improvement of validation systems, documents, procedures, and tools.
• Ability to work efficiently and independently with some guidance.
• Very analytical and detail oriented.
• Works in a neat, orderly, and safe manner, constantly seeking to improve methods and the safety of others.
• Other duties as assigned.

WORK EXPERIENCE AND REQUIREMENTS

• 3 – 7 years of validation experience in a FDA-regulated industry (preferably pharmaceutical).
• Thorough knowledge of FDA/ISO/GMP requirements
• Excellent written and oral communications skills with a strong emphasis on organizational capabilities.
• Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.
• Demonstrated proficiency in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint).

EDUCATION REQUIREMENTS

• BS in an Engineering or Scientific Discipline, Business, or a related field preferred.  Experience in lieu of education will be considered.