Process Engineer III

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 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 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 and/or approve SOPs, as needed, to support GMP manufacturing.

Develop process validation protocols and mentor younger engineers as to validation requirements.

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 and department

At the discretion of VP or Director of Process Engineering, approve masterbatch records and/or protocols in areas where the engineer is deemed a subject matter expert

Interacts regularly with senior technical peers and colleagues and executive management

Demonstrates leadership skills and the ability to influence

Has proficiency in more than one functional area (process, project, etc.)

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

QUALIFICATION:

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.

Preferred Additional

Background in or working knowledge of Pharmaceutical industry and

cGMP’ s preferable

~5–20 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

PHYSICAL DEMANDS

Must be able to lift and maneuver 40 pounds.

Must be capable of standing for extended periods of time.

Must be able to wear personal protection equipment which includes gloves and respirator, when required.