Validation Engineer

Our BusinessAdare Pharma Solutions is a global Contract Development and Manufacturing Organization (CDMO) with locations across North America and Italy. We offer a wide range of manufacturing, packaging, and research and development services. Our clients range from growing biotech firms advancing groundbreaking clinical trials to established pharmaceutical companies producing high volumes of approved, widely used medicines.

By combining top talent from the life sciences industry with modern research and manufacturing technologies, Adare enables clients to deliver potentially lifesaving medicines in more easily consumable formats - particularly for patients such as infants or the elderly. This is the meaning behind “Transforming Drug Delivery – Transforming Lives.”

Our CultureWhen it comes to being an employee of Adare, although we are located across multiple countries and come from diverse backgrounds, we work together toward a common purpose. Supported by leadership that is experienced and highly regarded in the industry, we are paving the way for a brighter and better future by attracting top talent from both within and beyond the CDMO space.

In addition to delivering high-quality results for our external clients, we foster a collaborative, client-centric culture internally - one where employees support one another, share knowledge, and encourage each other to bring their best selves to work each day.

Why Come to Adare?Adare is Private Equity owned and poised for growth. Employees are provided with internal development opportunities to progress within the organization, enhancing their professional skills and industry knowledge through Adare’s investment in their growth.

We offer a variety of fields to embark in, including manufacturing, engineering, quality, chemistry, formulations, analytical research and development, finance, supply chain, sales, marketing, project management, human resources, and environmental health and safety. Our benefits package is highly competitive, offering medical, dental, and vision coverage; a retirement plan with company match, paid time off and company holidays, tuition reimbursement with no waiting period, life insurance, pet insurance, Flexible Spending Accounts (medical and dependent care), and disability coverage.

Position

Validation Engineer

Location

Vandalia, Ohio

Summary

The Validation Engineer is a critical member of the Manufacturing Science and Technology team, and will have responsibility for Process Validation, Cleaning Validation, Facility Qualification, and Equipment Qualification.

Responsibilities

Process Validation:

Work on all aspects of manufacturing process validation and revalidation, including related change controls.

Evaluate Critical Process Parameters and Critical Quality Attributes for new products.  Create sampling and testing plan for each process validation protocol.

Technical writing:  Write process validation protocols and validation summary reports.

Perform risk assessments of formulations and manufacturing processes.

Document and close out deviations to protocol.  Investigate causes for failing analytical results and process failures.

Provides protocol training to Manufacturing and Quality Control personnel.

Cleaning Validation:

Work on all aspects of cleaning validation and verification, including related change controls.

Validate the cleaning processes for new equipment and for the cleaning process in existing equipment after making new products.

Maintain the ongoing annual cleaning verification program.

Evaluate alternate cleaning agents and methods as needed and their potential impact on the validated status of cleaning processes.

Technical writing for cleaning validation protocols and validation summary reports.  Write evaluations of alternate cleaning agents and processes.  Write/evaluate new cleaning SOPs.

Facility Qualification:

Work on all aspects of facility qualification and re-qualification, including related change controls.

Evaluate changes to the facility and their impact on the validated status of the cGMP rooms/areas within the facility.

Technical writing for facility qualification protocols and validation summary reports.  Write evaluations of changes being made to the facility.

Equipment Qualification:

Work on all aspects of equipment qualification and re-qualification, including related change controls.

Work on aspects of critical utility qualification and re-qualification, including related change controls.

Maintain the periodic equipment re-qualification program.

Technical experience and/or expertise in the operation of pharmaceutical equipment including but not limited to tablet presses, blenders, fluid beds, roller compactors, pan coaters, mixers, ovens, capsule fillers, packaging equipment, and other pharmaceutical equipment.

Technical writing: Write equipment qualification protocols and validation summary reports.  Write evaluations of changes being made to the equipment as necessary.

Experience, Education, and Skills Required

BS/BA degree from a four-year accredited university or college in Biology, Chemistry, Engineering, or related field; 

3+ years’ experience with Validation and Qualification activities in a GMP environment 

Ability to continually learn on the job: new equipment, new manufacturing technologies, new raw materials, etc.

Problem solving and trouble-shooting abilities 

Capable of scientific observation of processes

Technical writing skills

Good working knowledge of “Good Manufacturing Practices”.

Proficient in Microsoft Office – Word, Excel, PowerPoint, Visio.  Statistical software such as JMP.

Ability to coordinate, contribute to, and work within cross-functional teams. 

Demonstrates mechanical aptitude.

Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

PRINCIPALS ONLYNO AGENCIES OR THIRD PARTIES