What are the responsibilities and job description for the Equipment Validation Specialist position at Bora Pharmaceuticals?
I. JOB SUMMARY
The Specialist position will design and prepare all protocols and reports related to novel and diverse validation activities. The candidate will focus on Cleaning, Equipment, Utilities, and Software Validation. The Engineer will network with senior internal and external personnel in their area of expertise and work on problems where analysis of data requires evaluation of identifiable factors and troubleshooting of abnormalities.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Write, execute, and approve validation and re-validation protocols and reports, (IQ / OQ / PQ), for the validation of new and existing processes, equipment, systems, etc.
- Write summary reports, following good documentation practices.
- Use Kaye Validator, DataTrace dataloggers, and / or Ellab ValSuite dataloggers to perform mapping studies.
- Write and revise SOPs as part of process improvements.
- Analyze statistical data to verify acceptable criteria.
- Develop testing strategies and rationale for equipment / systems.
- Provide technical support / troubleshooting for process and equipment issues.
- Attend production and team meetings, as required.
- Maintain close contact with manufacturing, facilities, and laboratory departments to assure effective communication on issues related to validation.
- Apply CGMP guidelines to all aspects of validation.
- Investigate / resolve deviations associated with validation studies.
- Assist with commissioning, FATs, and SATs.
- Author technical documents such as protocols, reports, deviations, gap analyses, risk assessments, etc.
- Provide technical and / or investigational support in troubleshooting and resolving manufacturing equipment issues.
- Support the technical transfer team, Project Management, and business development in determining and planning studies required for new products.
- Perform periodic review of equipment / systems.
- Critically review complex data to ensure completeness, accuracy and compliance.
- Qualify change parts for fillers, cappers, vial washers, labeler, cartoner, and serialization machines to support new products.
- Write and revise SOPs and Master Plans biennially or as part of process improvements.
- Maintain close contact with Production, Facilities Maintenance, and Laboratory Services to assure effective communication on validation issues.
- Apply CGMP and CGDP to all areas of work.
- Support regulatory services with CMC preparation, product reviews and Client and Regulatory audits.
- Assist in cleaning validation activities and plans associated with projects at the site.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
BS in Science or Engineering with minimum of 5 years of equivalent job experience in pharmaceutical manufacturing.
IV. PHYSICAL / MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
The physical / mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.
The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.
Compensation Range :
83,400.00 - $125,100.00
Bora Pharmaceuticals Injectables, Inc. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals Injectables, Inc. will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category
Salary : $83,400 - $125,100
