IT-Automation Support Resource
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Job Summary
Resources Qualifications
BS in electrical computer mechanical engineering and or related fields.
Five-(5) years of experience in pharmaceutical operations or Manufacturing processes with proven project management skills which four (4) of the five years experience must be in Process automation in pharmaceutical environment with two (2) years experience in computerized systems validation.
Proficient knowledge of computer system life cycle concepts change control systems and FDA regulatory requirements including 21 CFR Part 11.
Proven experience issuing and preparing Computerized Functional Requirements and Design Specifications.
In-depth knowledge of the science and physics involved in the design installation commissioning and validation/qualification of computerized systems and PLCs as applied to pharmaceutical production environment.
Broad knowledge of relevant governmental regulations cGMPs and guidelines pertaining to a biopharmaceutical manufacturing plant.
Experience with external and internal regulatory audits (FDA EMA Otsuka Sanofi etc.).
Knowledge of pharmaceutical business processes and equipment.
Knowledge of mechanical concepts electrical controls theory and electronic circuitry.
Proven skills in projects management systems development and implementation of manufacturing MES Systems and quality related systems.
Ability to manage and operate computer software packages used for data acquisition systems and PLC programming including (not limited to) Rockwell Automation platform visualization and programming solutions/tools.
Knowledge of data historian (including but not limited to OSI PI-FactoryTalk Historian) Databases (MS SQL) and networking infrastructure and topologies.
Able to read interpret and understands electrical/mechanical drawings.
Ability to review SOPs and work instructions.
Flexible and responsible.
Significant abilities and aptitude to analyze data detecting inconsistencies determining relative importance and to solve complex technical situations based on data.
Bilingual English/Spanish both written and verbal are required.
Able to interact effectively with people to establish and maintain excellent working relationship with internal and external customers at all organizational levels and disciplines in such a way to facilitate the validation/qualification work.
Able to plan and prioritize multiple complex activities simultaneously (i.e. installation integration commissioning and validations/qualifications timelines etc.) by using sound Project Management Skills.
Willing to work irregular hours rotating shifts weekends and holidays when necessary.
Self-starter and well organized.
Strong interpersonal skills to establish and maintain effective working relationships across all organizational levels and disciplines.
Ability to keep work pace and/or meet deadlines.
Ability to exercise good judgment.
BS in electrical computer mechanical engineering and or related fields.
Five-(5) years of experience in pharmaceutical operations or Manufacturing processes with proven project management skills which four (4) of the five years experience must be in Process automation in pharmaceutical environment with two (2) years experience in computerized systems validation.
Proficient knowledge of computer system life cycle concepts change control systems and FDA regulatory requirements including 21 CFR Part 11.
Proven experience issuing and preparing Computerized Functional Requirements and Design Specifications.
In-depth knowledge of the science and physics involved in the design installation commissioning and validation/qualification of computerized systems and PLCs as applied to pharmaceutical production environment.
Broad knowledge of relevant governmental regulations cGMPs and guidelines pertaining to a biopharmaceutical manufacturing plant.
Experience with external and internal regulatory audits (FDA EMA Otsuka Sanofi etc.).
Knowledge of pharmaceutical business processes and equipment.
Knowledge of mechanical concepts electrical controls theory and electronic circuitry.
Proven skills in projects management systems development and implementation of manufacturing MES Systems and quality related systems.
Ability to manage and operate computer software packages used for data acquisition systems and PLC programming including (not limited to) Rockwell Automation platform visualization and programming solutions/tools.
Knowledge of data historian (including but not limited to OSI PI-FactoryTalk Historian) Databases (MS SQL) and networking infrastructure and topologies.
Able to read interpret and understands electrical/mechanical drawings.
Ability to review SOPs and work instructions.
Flexible and responsible.
Significant abilities and aptitude to analyze data detecting inconsistencies determining relative importance and to solve complex technical situations based on data.
Bilingual English/Spanish both written and verbal are required.
Able to interact effectively with people to establish and maintain excellent working relationship with internal and external customers at all organizational levels and disciplines in such a way to facilitate the validation/qualification work.
Able to plan and prioritize multiple complex activities simultaneously (i.e. installation integration commissioning and validations/qualifications timelines etc.) by using sound Project Management Skills.
Willing to work irregular hours rotating shifts weekends and holidays when necessary.
Self-starter and well organized.
Strong interpersonal skills to establish and maintain effective working relationships across all organizational levels and disciplines.
Ability to keep work pace and/or meet deadlines.
Ability to exercise good judgment.
Key Skills
- Baan
- English Language
- Ideas
- Access
- Games
- Application Management
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