Process Engineer

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.

MAJOR DUTIES AND RESPONSIBILITIES:

• Provide technical support for manufacturing. Conduct technical investigations, write reports, and aid in the close-out of deviations.
• 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.
• 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, packaging, and cleaning validation protocols and reports.
• Write/execute protocols (IQ/OQ/PQ) as required.
• Interact 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.

QUALIFICATIONS:

Required

• Bachelor’s degree in engineering (Chemical Preferred).
• Background in or working knowledge of chemical manufacturing industry.
• Must be able to lift to 20 pounds on a regular basis.

Preferred Additional

• Background in or working knowledge of pharmaceutical industry and cGMP’ s preferable.
• 0–5 years’ experience in Chemical Manufacturing

CRITICAL SKILLS AND ABILITIES:

• Demonstrates strong technical 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.
• Must be capable of detailed record keeping and communicating results to others.

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 are 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

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 a respirator, when required.