Our client a well-known Maryland based CDMO is seeking a Validation Process Engineer to achieve reliability/compliance in the manufacturing of cosmetics, pharma (Rx/OTC) and other medical products.
Position Overview:
The Validation Process Engineer will provide direct technical support to Engineering, Operations and the Quality Unit, in order to achieve the reliable and compliant manufacture of cosmetics, medical devices and drug products (Rx and OTC). This position reports directly to the Manager, Tech Services.
Benefits:
Full Comprehensive health insurance including medical, dental, vision, 401K plan, paid time off and bonuses.
Position Responsibilities:
- Provide direct technical support to achieve the reliable and compliant manufacture of cosmetics, medical devices and drug products via the use of validated equipment and manufacturing processes, work instructions and procedures.
- Understand the scientific principles required for cosmetic, medical device and drug products, including the interaction of the chemistry, equipment, processes, and container closure systems.
- Develop and prepare protocols and summary reports for operational qualifications, engineering studies, and for process transfers and scale-ups.
- Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, corrective and preventative actions, deviation investigations, manufacturing batch records and procedures.
- Investigate and resolve manufacturing issues that lead to production delays and technical issues with the product.
- Successful application of root cause analysis and systematic problem solving.
- Work within or lead cross-functional teams in positive fashion to implement manufacturing objectives, and deliver on business plan and quality objectives.
- Attend and participate in process team meetings for production issues, resolution and process improvements.
- Lead and/or participate as a team member on process improvements for the production area. These can include but not limited to experiments, modeling and/or production data analysis to improve process control, yield, purity, and/or productivity.
- Perform and summarize improvement opportunities in technical reports through statistical analysis, plant trials, investigations, research, lab trials, and process/unit operations modeling.
Personal Attributes:
- Highly motivated, self-starter, high energy level
- Team player; strong interpersonal skills
- Demonstrated decision making
- Multi-tasking
- Results oriented and science driven
- Excellent written, organizational, presentation and communication skills
Education/Experience:
- Bachelor’s degree in a scientific discipline or equivalent experience (g. engineering. chemistry, biochemistry, etc.) / B.S. in Chemical Engineering is highly preferred.
- Technical/Scientific knowledge of solutions, semi-solids, topical and transdermal dosage forms is highly preferred. Has a functional understanding of the operation of production equipment involved in the manufacturing process.
- Excellent written and oral communication skills.
- Ability to work with Microsoft Excel, Word, Visio and PowerPoint
- Demonstrated team participation and management skills required.
- Cleaning validation experience a plus.
- Ability to use statistical tools such as JMP/Mini-Tab to evaluate the process capability of the manufacturing process.
- A clear understanding of ISO and cGMP regulations.