Process Engineer II

THE COMPANY:

Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience through creativity and invention; delivering our world class Marketing Partners unmatched formulations, innovative packaging and cost effective, reliable supply.

Formulated Solutions is and shall always be a company of people with the knowledge and dedication to provide our Marketing Partners with a single source solution for delivering quality and innovative products to market. We shall embrace changes and new opportunities as a vehicle to continually develop and grow sustainable relationships. As a company we shall never accept anything less than a culture that fosters creativity, growth, and profitability for both our Partners and the company.

PRIMARY PURPOSE:

Provide engineering services for pilot batches, validation, commercial product support, and capital projects.

MAJOR DUTIES AND RESPONSIBILITIES:

· Provide technical support for manufacturing. Conduct technical investigations, write reports and provide assistance in the close-out of deviations.

· Lead or support technology transfers by conducting laboratory and/or pilot plant experiments, and providing technical risk assessments for new manufacturing processes. Interpret and communicate results to the technology transfer team.

· Designs and/or implements manufacturing processes, equipment (from pilot to fully operational) for complex products.

· Utilize lean or six sigma tools to generate process improvements for inline products.

· Keep current on regulatory and quality requirements for manufacturing.

· Write SOPs, as needed, to support GMP manufacturing.

· Develop process validation protocols.

· Write/execute protocols (IQ/OQ/PQ) for equipment as required

· Develops user specifications/ requirements for equipment purchase and/ or requirements for process validation

· Makes decisions with designated assignments that influence the goals of the project

· At the discretion of VP or Director of Engineering, approve master batch records in area where the engineer is deemed a subject matter expert

· Interacts regularly with senior technical peers and colleagues

· Demonstrates leadership skills and the ability to influence

· Completes assignments in more than one functional area (process, project, etc.)

· Other functions as required to support existing operations and customer focused projects.

QUALIFICATION:

A. Required

• Bachelor’s degree in Engineering (Chemical preferred).

• Background in or working knowledge of chemical manufacturing industry

• Must be able to lift up to 20 pounds on a regular basis.

B. Preferred Additional

· Background in or working knowledge of Pharmaceutical industry and cGMP’ s preferable

· 2–15 years’ experience in Chemical Manufacturing

CRITICAL SKILLS AND ABILITIES:

· Demonstrates strong technical and/or regulatory expertise and ability to adapt to changing circumstances

· Excellent communication skills

· Ability to wear Personal Protective Equipment including a respirator, gloves, and eye protection

· Ability to perform work in a manufacturing environment where there is exposure to occupational hazards.

· Must be able to work extended hours on evenings and weekends as required.

· Employee must be punctual and on time.

· Must be capable of detailed record keeping and communicating results to others.

· Project skills appropriate for leadership of tech transfer projects

COMPUTER SKILLS:

· Ability to operate the following office equipment: computer, telephone, photocopier, facsimile, and calculator

· Power Point, Word, Excel and a basic understanding of Microsoft media applications is required.

Technical Skills and Experience (if applicable):

· Technical skills appropriate for execution of technical transfers of topical products

· Data analysis with a good understanding of statistical process control

· PAT experience is preferred

Education and/or Training

· Bachelor’s degree in Chemical Engineering, MS preferred