CAREERS
| Validation Engineer |
| Date: December 21, 2011 |
| Reporting To:Lead Validation Engineer |
| Department:Validation |
| Location:Inverin, Co. Galway, Ireland |
ESSENTIAL DUTIES AND RESPONSIBILITIES:
To perform this job successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
- Accountable for writing, executing & reporting of all validation activities including but not limited to (DQ / FAT / IQ / OQ / PQ / PPQ / pFMEA).
- Validation/Qualification projects will be across a range of production areas which may include Sterilisation, Filling, Process, Cleaning, Software, Utility and Facility projects.
- Generation, execution and close out of validation projects relating to existing products and new product introductions.
- Participates in project teams and assists in determining project schedules and the relevance of appropriate levels of validation.
- Process Validation against Corporate SOP/FDA/EMEA requirements.
- Statistical analysis of data to determine process capability.
- Execution and documenting of process risk assessment / failure mode and effects analysis.
- Perform validation functional testing as required.
- Track and resolve exceptions during qualification activities.
- Ensure all information is recorded correctly and compliant with GDP.
- Execution of validation protocols.
- Development of project plans for Validation/Qualification projects.
- Perform other duties as assigned.
QUALIFICATIONS
The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.
KNOWLEDGE
Must possess knowledge of pharmaceutical and medical device regulatory requirement for FDA and IMB regulated environments.
- Knowledge of Pharma/Medical product manufacturing, especially sterilisation processes and/or filling operations.
- Experience in process, software, filling and sterilisation process validation.
- Experience in mixing & cleaning validation with understanding of associated chemistry and microbiology requirements.
- Experience with statistical software packages.
- Ability to understand manufacturing processes.
SKILLS AND ABILITIES
- Must possess strong project management and organizational skills. Self-motivation and drive.
- Excellent interpersonal, communication (written & oral) & technical report writing skills.
- Must be flexible and able to manage multiple priorities simultaneously.
SUPERVISION
Position functions with supervision.
EDUCATION/EXPERIENCE
Minimum of a Bachelor's Degree in a Technical, Science, Production or Process discipline and a minimum of three years’ experience in a validation role within the Pharmaceutical industry or a similar operating environment with in-depth knowledge of validation processes.
However, a combination of experience and/or education will be taken into consideration.
LICENSES/CERTIFICATIONS
None required.
LANGUAGE SKILLS
Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group of departments.
MATHEMATICAL SKILLS
Ability to add, subtract, multiply and divide.
REASONING ABILITY
Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping.
May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Medium lifting requirements.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Normal office situation.
TO APPLY
All applications should be forwarded to careers@bionichepharma.com
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