Validation Engineer

Our Business
Adare 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 Culture
When 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
In this position, the Engineer will utilize their formulations and/or technical services background to support Manufacturing. Responsibilities encompass technical knowledge in support of solid oral dose manufacturing. As a collaborative partner, they will utilize their expertise in all aspects of product scale up, contract manufacturing, validation and technical support of 3rd party manufacturing as well as internal support of solid oral dose facilities in North America. Will be a key contributor and practitioner in lean manufacturing projects across multiple sites and manage various transfer and scale-up projects throughout the supply chain.

Responsibilities

• Manage scale up of commercial products, manufacturing feasibility batches, writing batch records and summarizing results for both internal and 3rd party manufacturing.
• Develop and execute studies for process, equipment, and cleaning validation activities related to bulk drug delivery and finished dosage formulations developed by Research and Development (R&D),products currently in commercial production, and technical transfers from customers or other Adare sites. These activities will be executed to Adare, customer, and regulatory, domestic and foreign, requirements.
• Provide technical training and support to departments supported by the Technical Services/Validation departments (Third party GSC, Manufacturing, etc).
• Update, review, and approve Standard Operating Procedures (SOPs), batch records, and other official documents and determine if validation or re-validation is required prior to approval of the new or changed procedure(s). Recommend new procedures or revisions as applicable.
• Participate in Factory Acceptance Testing (FAT) and/or due diligence testing and investigations.
• Collaborate with validation projects within the facility including execution of protocols and report writing.
• 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.
• Operate independently and provide feedback and solutions to technical issues for both internal projects and projects at 3rd party sites.
• Support the engineering department with capital projects or trouble shooting of equipment and processes within the facility.
• Be a key contributor and practitioner of lean manufacturing programs within the facility.
• Attends work on a regular and predictable basis.
• Completes assigned tasks in a safe manner and in a constant state of alertness.
• Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code.
• Works in a cooperative manner with managers, supervisors, coworkers, customers, and the public.
• Works effectively under deadlines.

Experience, Education, and Skills Required

• BS/BA degree from a four-year accredited university or college in Biology, Chemistry, Engineering, or related field; plus 3-5 years of related experience required.
• Possess mechanical aptitude
• Must have good working knowledge of the "Good Manufacturing Practices"
• Ability to continually learn on the job: new equipment, new manufacturing technologies, new raw materials, etc.
• Problem solving and trouble-shooting abilities. Ability to determine the root causes of failures and problems.
• Capable of scientific observation of processes; has ability to accurately record observations and draw conclusions from them.
• Technical writing ability. Ability to explain scientific and technical issues to a non-specialist audience.
• Excellent interpersonal written and oral communication skills.
• Proficient in Microsoft Office - Word, Excel, PowerPoint, Visio. Statistical software such as JMP.
• Ability to coordinate, contribute to, and work within cross-functional teams.
• Able to prioritize duties and work on multiple projects with minimal supervision.
• Possesses good attention to detail and excellent organizational skills.
• Demonstrates mechanical aptitude.
• Operate independently and provide feedback and solutions to technical issues for both internal projects and projects at 3rd party sites.
• Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code.
• Works in a cooperative manner with managers, supervisors, coworkers, customers, and the public.
• Works effectively under deadlines.

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 ONLY
NO AGENCIES OR THIRD PARTIES

Attention Job Seekers and Applicants: Please be aware of attempted recruiting scams. While Adare does conduct virtual interviews for some positions, we do NOT use Skype or Google Meet. If you are contacted by someone regarding a job opportunity, please be vigilant in reviewing the details of any and all correspondence. Here are some things to look out for: bad grammar; font inconsistencies or formatting irregularity: logos not properly sized, stretched out, blurred; numerous different font styles and sizes within the content of an email or letter; company impersonators (postings that mirror a reputable company, but there's no link to the business) mismatched email or website domains, or there is difficulty with locating an address, business phone number, and/or email address, financial requests: Do not provide payment or account credentials as part of the application process. Legitimate companies should not require transfers, checks, gift cards or the wiring of funds as a condition of the application process. Additionally, equipment purchases: be cautious if a company asks you to purchase your own equipment (computers, iPads, mobile phones) and requests you to mail it to their IT department. Applicant Follow-up Questions: Proceed with caution if you receive an application follow-up request that requires you to click on a link to answer additional questions; especially if the questions request personal information such as a social security number. General anonymity: proceed with caution if you can't quickly verify the identity of the poster.