Job Title: MS&T Specialist II/Process Engineer
Location: Davie, FL - 33314 (Onsite Role)
Dura tion: 6 months, can convert to permanent employee based on the performance
Shift Time: 8 am 5 pm on regular hours, however, may need off-shift support
# Of Hours Day: 8 hours
Schedule: Mon - Fri
Job Type: Contract
Pay Rate: $$36 - $40 /hr on w2
Top Skills: Bachelor's Degree, Process Engineering, Pharmaceutical

Education/Certification/Experience:
Requires a bachelors degree in Chemical Engineering, Pharmaceutical Engineering, Pharmaceutical Manufacturing, or Pharmaceutical Technology or Masters/Ph.D. in Chemistry with a minimum of 4 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 Client 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.

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.

Responsibilities:
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.
Perform studies to support necessary equipment and system PQ's and PPQs to assure compliance in all manufacturing and support areas, analyze data using appropriate statistical tools.
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.
Implement and use of new pharmaceutical manufacturing technologies including melt extrusion, spray drying, extrusion spheronization, spray congealing, laser drills, nano particulates, continuous manufacturing, NIR, PAT, etcetera.
Work with limited guidance from supervisor or seniors to drive projects to completion.
Perform technical analysis to understand and reduce technology transfer risk, estimate cycle time, improve equipment fit, and implement required technologies.
Design, develop and optimize process simulation techniques for process optimization and scale up.
Previous Pharma experience (0-1 yr)
Experience in HPLC, Assay, Dissolution, Uniformity, Karl Fischer, Particle Size, Empower, Chemstation
Minimum BS/BA in Chemistry, or BS in a Related Science
Exp. in cGMP enivronment is nice to have

Job Type: Contract

Salary: $30.00 - $40.00 per hour

Schedule:

• Day shift
• Monday to Friday

Ability to commute/relocate:

• Davie, FL 33312: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Work Location: One location

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