Purpose and Scope Support the validation program including design, installation, and operational qualification of equipment, performance validation for all manufacturing processes and lab equipment qualification.

Essential Duties & Responsibilities Responsible for the change management for validated processes and equipment. Write and maintain work instructions, SOPs, and Validation Protocols. Complete re-qualification and periodic review activities as required per the quarterly schedule. Plans and coordinates the specific validation activities for projects. Provide validation input to Engineering and Maintenance in equipment purchase requirements. Generate protocols and perform execution in the following validation areas. Temperature mapping of warehouses and temperature-controlled chambers. Aseptic manufacturing equipment IQ and OQ Non-sterile manufacturing equipment IQ and OQ Utility system IQ and OQ Laboratory equipment IQ and OQ Automated systems qualifications Sterilization process PQ (Autoclaves, Dry Heat Ovens, Process SIP, VPHP) Interface with Engineering, Facilities, Regulatory, and Manufacturing personnel as needed. Perform other related duties as assigned.

Core Values The Validation Engineer I is expected to operate within the framework of Tolmar's Core Values: Consistently operate with the highest standards of ethics and compliance. Take ownership of your actions, success and setbacks. Respect each other and understand that honest collaboration is at the heart of our company success. Go the extra mile to make things happen. Be committed to all we do and the patients we serve. Embrace change with enthusiasm. Strive to learn about and understand the needs of customers and patients and take action with great speed and efficiency no matter the task.

Knowledge, Skills & Abilities Proficient knowledge with MS Office. Knowledge of GMP regulations and validation guidelines. Knowledge and experience in writing protocols and following procedures. Knowledge of validation tools such as Kaye Validator / Elab Systems. Excellent oral and written communication skills demonstrated through interactions internally and externally. Effective organization and project management skills. Effective troubleshooting and problem-solving skills. Ability to maintain gowning requirements as needed to access controlled areas. Ability to manage multiple projects simultaneously. Ability to work both independently and in conjunction with a team. Develop and implement creative solutions to problems.

Education & Experience Bachelor's in an engineering discipline, chemical or mechanical engineering preferred. Degrees in other scientific disciplines may be considered. One or more years' experience in an engineering, manufacturing, laboratory environments within the Pharmaceutical/Biotech industry. Understanding of requirements (GMP, Validation, CFR, etc.) of working within an FDA regulated industry.

Compensation and Benefits Annual pay range $70,000 - $72,000 Benefits information: https://www.tolmar.com/careers/employee-benefits Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package... for full information follow application link.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities