The Validation Engineer II will develop and execute validation plans, protocols and reports that support the business needs of the company. The position will oversee and support the qualification and validation of the pharmaceutical manufacturing processes and ensure that the facility, systems and processes perform according to internal specifications, comply with current GMPs and are maintained in a validated state. This position will report into the Manager, Validation.
Essential Duties and Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
- The incumbent will act as a Subject Matter Expert (SME) for a designated discipline/s. Focusing on Packaging, Equipment and Facilities and/or Cleaning Validation, the incumbent will develop and execute validation protocols associated with the installation, operation and performance qualification and requalification of equipment, utilities and processes used in the manufacture of aseptically produced parenteral pharmaceuticals, including lyophilized solutions.
- The SME will provide technical expertise during design, evaluation and procurement of new equipment, utilities or processes.
- Maintain life cycle documentation for equipment and systems, including User Requirements Specifications, Functional Specifications, Hardware Design Specifications, Software Design Specifications, and Configuration Specifications.
- Support all aspects of the Validation Life Cycle, from design through operation and improvement.
- Plan, coordinate and manage site-specific validation project activities including protocol development/approval, work schedules and lifecycle documentation.
- Review qualification/requalification packages for completeness and accuracy, sound rationale, compliance with validation policies and procedures and accurate data analysis.
- Provide and document training to personnel performing validation activities.
- Provide the technical input to address validation deviations and provide assessments for change requests and identify qualification requirements to ensure compliance to GMP’s and that the validated state is maintained.
- Coordinate protocol approvals and produce accurate summary reports.
- Develop or contribute to the development of SOPs related to equipment or processes for which the incumbent serves as SME.
- Remain current with FDA guidance’s and requirements regarding the validation of aseptic manufacturing processes; ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements.
- Provide technical and troubleshooting assistance for identifying and addressing manufacturing anomalies or deviations.
- Interface with Quality, Manufacturing, Packaging and Engineering groups to facilitate and drive validation execution and completion.
- Perform any other tasks/duties as assigned by management.
Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
- Bachelor’s Degree in Life Sciences, Engineering or equivalent and 3 years of validation experience in a Pharmaceutical or related industry OR
- Associate’s Degree and 5 years of validation experience in a Pharmaceutical or related industry OR
- High School Diploma / GED and 8 years experience in a Pharmaceutical or related industry
- Strong knowledge and understanding of cGMP regulations and practices pertaining to validation principals, manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectations and industry trends.
- Ability to read/interpret engineering drawings and design documents.
- Strong knowledge of MS-Office software and PC Skills required.
- Good technical writing skills.
- Excellent communication, problem-solving, planning and organization skills.
- Ability to work independently with minimum supervision, including making sound decisions and managing priorities that are in alignment with departmental and site directives.
- Ability to mentor and direct junior team members.
- Ability to work within a team-oriented environment.
- Ability to work overtime as needed.
- Travel for off site training and projects may be required on occasion (<10%)
Physical Environment and Requirements
- Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
- Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.
- Employee must be able to occasionally lift and/or move up to 15 pounds.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
Applicants have rights under Federal Employment Laws.
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