Process Engineer I

Duration: 6+ Months (40hrs/weeks)

Description:

M-F 9 to 5 PM ( 8 hours)

Mgr seeking core formulation or process development experience, verses lab and quality experience

 

POSITION SUMMARY

This position is responsible for performing activities related to critical aspects of products and processes, including process development, pre-validation and optimization of solid oral dosage forms after Abbreviated New Drug Application (ANDA) filing throughout product launch and commercial lifecycle including validation. Executes studies with Research and Development (R & D), Laboratory Technical Services (LTS), manufacturing and planning. Maintains of expertise related to formulation, raw material properties and manufacturing processes. Identifies, analyzes and suggests corrective actions to optimize procedures, processes, materials, technology and regulatory compliance issues. Provides direction and training to other staff, technicians and manufacturing operators.

 

ESSENTIAL AREAS OF RESPONSIBILITY

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

• Act as Subject Matter Expert (SME) for new product launches and commercial products on site.

• Point of contact for providing support for the other departments.

• Critical thinking and independently driving projects to completion.

• Providing process-engineering expertise for technology transfer, from pre-validation through commercial lifecycle for modified release solid oral dosage form manufacturing including scale up, validation and lifecycle changes.

• Perform technical analysis to understand and reduce technology transfer risk, estimate cycle time, improve equipment fit, and implement required technologies.

• Provide continued technical leadership to commercial operations and ensure cost effective and robust manufacturing processes for various unit operations including blending, sizing, compression, coating, fluid bed processing, and novel technologies.

• Contributing to business teams through innovation, strategic input, and industry knowledge to trouble shoot and achieve cost leadership.

In accordance with the Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled

individuals. However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose an undue

hardship on the Company.

The requirements and responsibilities in this position description do not create an employment contract and are not meant to be all-inclusive. The incumbent

is responsible to ensure compliance with all laws, regulations, codes, standards and company policies relevant to this position. This document in no way

states or implies that only the duties described above are to be performed by the incumbent. The incumbent will be expected to follow instructions and

perform duties as required by his or her supervisor and understand that aspects of their position may be changed by the Company on an as-needed basis.

• Perform engineering analysis of process execution, recommends opportunities for improvement with plant efficiency and risk mitigation as goals, and captures analysis in campaign summary documents.

• Provide process expertise in post-batch record review and analysis.

• Act as a quality events investigator for assigned projects.

• Lead documentation for equipment, lead FMEAs, recommend equipment modifications as needed for validation optimization, Analyze statistical data from qualification, product or functional specifications to determine conformance with standards and established quality requirements.

• Maintain product during lifecycle (stage 3 – CPV) using appropriate statistical tools.

• Implement and lead use of new pharmaceutical manufacturing technologies including melt extrusion, spray drying, extrusion – spheronization, spray congealing, laser drills, nano particulates, continuous manufacturing, NIR, PAT, etcetera.

• Lead and execute material changes, process changes, cost reduction projects and CPV.

• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.

• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), and Standard Operating Procedures (SOP’s) and Batch Record instructions.

• Responsible for performing additional related duties as assigned.

POSITION REQUIREMENTS

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:

• Requires a bachelor’s degree pharmacy, engineering or science with a minimum of 10 years’ relevant experience in the field of Pharmaceutical manufacturing and/or pharmaceutical formulation and/or pharmaceutical process development and pre-validation OR related field.

• Advanced degree is preferred.

• A combination of education and experience will be considered.

 

Skills/Knowledge/Abilities:

• Understanding of various unit operations used in conventional and novel oral solid dosage manufacturing.

• Comply with FDA regulations at all times.

• Business, scientific and personal computer hardware and software applications.

• Skill levels in MS Office including proficiency in Word, PowerPoint, Excel and SharePoint.

• Must be able to maintain the highest levels of confidentiality, integrity and discretion.

• Excellent verbal, written, and interpersonal skills required.

 

Problem Solving:

• Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.

In accordance with the Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled

individuals. However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose an undue

hardship on the Company.

The requirements and responsibilities in this position description do not create an employment contract and are not meant to be all-inclusive. The incumbent

is responsible to ensure compliance with all laws, regulations, codes, standards and company policies relevant to this position. This document in no way

states or implies that only the duties described above are to be performed by the incumbent. The incumbent will be expected to follow instructions and

perform duties as required by his or her supervisor and understand that aspects of their position may be changed by the Company on an as-needed basis.

• Seeks out all resources when selecting methods and techniques for obtaining results.

• Acts independently and proactively to recommend and administer methods and procedures for problem resolution.

• Able to identify solutions to general problems through collaboration and creativity.

 

1st Shift (M-F)