- Communication skills
- Writing skills
- Microsoft Office
- Project management
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
Generate protocols and perform execution in the following validation areas;
Aseptic manufacturing equipment IQ and OQ
Non-sterile manufacturing equipment IQ and OQ
Temperature mapping of warehouses and temperature controlled chambers
Sterilization process PQ (Autoclaves, Dry Heat Ovens, Process SIP, VPHP)
Utility system IQ and OQ
Laboratory equipment IQ and OQ
Maintain re-qualification schedules and perform activities in a timely manner.
Plans and coordinates the specific validation activities for projects.
Responsible for the change management for validated processes and equipment.
Write and maintain project Validation Master Plans.
Interface with Engineering, Facilities, Regulatory and Compliance, Laboratory and Manufacturing personnel as needed and provide validation input.
Provide validation guidance to site staff who will write and execute protocols.
Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
Perform other related duties as assigned.
Knowledge, Skills & Abilities
Knowledge of GMP regulations and validation guidelines
Knowledge and experience in writing validation protocols.
Ability to maintain gowning requirements as needed to access controlled areas.
Knowledge of validation tools such as Kaye Validator or similar temperature monitoring and data collection device.
Proficient knowledge with MS Office
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 manage multiple projects.
Ability to work both independently and in conjunction with a team.
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.
Education & Experience
Bachelor’s degree in Engineering or Science related field.
Good technical skills and the ability to understand technical documentation such as equipment manuals or drawings.
Three or more years’ experience in the pharmaceutical industry. Two years of validation experience required.
Validation experience in a least two validation areas.
Work may require occasional weekend and/or evening work.
Work inside manufacturing clean rooms where gowning is required.
Bachelors or better in Engineering or related field
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)