*NEW STARTING RATES*

JOB SUMMARY:
The Process Validation Engineer I 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 department head or Senior Process Validation Engineer.

PHYSICAL / MENTAL DEMANDS

• Job is a mixture of sedentary work and periods of light work (Movement of materials less than 50lbs) as required.
• Frequent standing, occasional walking, pushing, pulling
• Occasional travel to support technical transfers or validation projects.
• Frequent bending, stooping and reaching and climbing of stairs.
• Employee must be able to receive, understand, and communicate verbal and written instruction and communicate in the English language.
• Ability to count, draft, read and distinguish numbers and symbols from schedules.

SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES:

1.1 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.

1.2 Understand the scientific principles required for cosmetic, medical device and drug products, including the interaction of the chemistry, equipment, processes, and container closure systems.

1.3 Prepare protocols and summary reports engineering and validations documents for blending and packaging process.

1.4 Prepare 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.

.5 Investigate and resolve manufacturing issues that lead to production delays and technical issues with the product.

1.6 Successful application of root cause analysis and systematic problem solving.

1.7 Work within or lead cross-functional teams in positive fashion to implement manufacturing objectives, and deliver on business plan and quality objectives.

1.8 Attend and participate in process team meetings for production issues, resolution and process improvements.

1.9 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.

1.10 Perform and summarize improvement opportunities in technical reports through statistical analysis, plant trials, investigations, research, lab trials, and process/unit operations modeling.

QUALIFICATIONS:

• Bachelors Degree in Chemistry, Microbiology, Engineering or any appropriate scientific discipline. Courses related to medical device, or cGMP preferred.
• Preferred Minimum five years working in a FDA/GMP manufacturing environment.
• Proven work record with good working knowledge of Current Good Manufacturing Practices pertaining to medical devices and pharmaceuticals

KNOWLEDGE / SKILLS REQUIREMENTS:

• Ability to interface and train all levels within the organization.

• Ability to prioritize assignments.
• Ability to manage multiple projects in a time sensitive environment.
• Ability to interact with customers, vendors on an as needed basis.
• Proven analytical, problem solving and troubleshooting skills.
• Excellent knowledge of Current Good Manufacturing Practices pertaining to medical devices, drug and pharmaceuticals.
• Knowledge of process validation activities.
• Ability to generate flow charts and graph data.
• Must work in a team environment (Successfully work with diverse people and opinions.)
• Strong written and oral communication skills. (Ability to report on changes in standards and on performance against standards).
• Results oriented (Ability to measure performance against established standards).
• Working knowledge of Standard Operating Procedures (SOPs)
• Flexibility to effectively respond to changing work requirements and challenges.
• PC familiarity with Windows operating systems; particularly excel and word. Functional use of internet and email. Also, must have a familiarity with internal software use in the quality function.
• Be able to work independently and autonomously
• Working knowledge of GMPs
• Working knowledge of validation and using risk-based approach (FMEA, PHA, etc.).
• Ability to read/interpret engineering drawings and design documents.
• Knowledge of Validation Lifecycle Approach (e.g. ASTM E2500)
• Conducting statistical analysis of validation test results.
• Working knowledge of ICH Q8, Q9, Q10 and other international regulatory requirements.
• Investigation / trouble shooting validation problems.