Validation Engineer

4 weeks ago

Vandalia Ohio, United States Adare Pharma Solutions Full time
Are you ready to join a growing, global drug development and manufacturing organization that puts people first?  Come to Adare  We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world.  Each role and every department within Adare offer you a unique, customized experience with a chance to make a real impact, and is critical to our success.  With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery

Join our mission at Adare

What can Adare offer you?

Medical/dental/vision/life – low employee premiums

401k with a highly competitive match

Generous PTO, including floating holidays

Career growth and internal opportunities

Tuition reimbursement

Relocation assistance

Performance-based bonus

Employee Recognition Programs

We are seeking to hire a Validation Engineer to contribute to our Validation and Technical Services Team…

If any of the below describes you, we would love to meet you

JOB SUMMARY

In this position, the Technical Services Validation Engineer will have the following areas of responsibility:  Process Validation, Cleaning Validation, Facility Qualification, and Equipment Qualification.

Responsibilities and Learning Opportunities

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: Write 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:  Write 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.

Requirements

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.

Stays current with FDA validation compliance requirements through attending courses, reading journal articles and FDA guidance documents and communications.

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.

Good working knowledge of “Good Manufacturing Practices”.

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.

Benefits

Medical/dental/vision/life – low employee premiums

401k with a highly competitive match

Generous PTO, including floating holidays

Career growth and internal opportunities

Tuition reimbursement

Relocation assistance

Performance-based bonus

Employee Recognition Programs

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