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.