This role will provide YOU the opportunity to lead key activities to progress YOUR career.
These responsibilities include some of the following:
Lead the computer system validation of instrumentation and control systems including process control, data collection and historian systems for analytics, building automation systems, and production equipment PLCs which are harmonized with our standards.
Accountable for the lifecycle scope for GxP Automation Systems starting with project initiation and continuing through the project phases of planning, design, procurement, construction, commissioning, and control system qualification/validation.
Provide technical leadership and accountability for computer system validation engineering standards and computer systems validation for all site manufacturing Automation Systems.
Accountable for ensuring the successful delivery and maintenance of the computerized system validation life cycle to ensure compliant and reliable Automation Systems.
Prepare, review, and approve Computerized System Validation (CSV) protocols, reports, and procedures for GxP computerized systems.
Develop the validation protocols, plans, and reports for validation of control systems.
Provide technical expertise and management for projects, review and approval of change controls, and audit all CSV documentation for compliance with current corporate, FDA and regulatory requirements.
Manage change controls for changes to computerized systems.
Provide technical support (particularly for validation for computerized systems) for existing instrumentation and automation systems.
Analyze repairs and maintenance requirements in order to proactively address system weaknesses.
Develop validation documentation and implement validation plans, instrumentation and control systems.
Provide formalized training to other engineers, technicians, qualification staff, etc. for practical implementation of CSV at site.
Training must be provided by Sr. CSV Engineer to groups of other site staff (engineers, technicians, etc.) for an overall minimum of 8 combined hours of training per each calendar year. Focus of training is to improve others capability, knowledge, and methods for practical implementation of CSV life cycle.
Interface with users, peers, and management to ensure appropriate input and integration of local and corporate standards.
Provide technical expertise during regulatory audits.
Author, review, revise, or approve Standard Operating Procedures (SOPs) as required.
Responsible for on time Compliance records of Automation Department.
Participate in site Operational Excellence initiatives.
Participate on cross-functional teams, who address specific problems, facilitate discussion and research, enabling procedures to become more efficient, and to build and enhance interdepartmental relationships.
Provide technical support (particularly for validation for computerized systems) for utility systems including but not limited to: purified water systems, compressed air systems, chilled water systems and steam systems.
Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.
Work on any assignment as directed.
Adhere to all our safety guidelines and procedures.
We are looking for professionals with these required skills to achieve our goals:
BS in Engineering with experience in Control Systems Engineering (Automation)
3 years Automation (industrial controls) experience required.
3 years minimum in Life Sciences industry.
At least 7 years of combined demonstrated experience in cGMP automation/computerized systems, quality, and compliance areas of Life Sciences industry.
Experience with 21 CFR Part 11 cGMP requirements for electronic records, electronic signatures, system validation strategies and documentation.
Experience with process controls equipment including for example PLCs, BMS, Batch, HMIs, SCADA systems, SQL relational database systems, and network equipment including design and debugging skills in a pharmaceutical or related industry.
Experience in technical writing, report generation of testing methodologies of automation systems.
If you have the following characteristics, it would be a plus:
BS in Control Systems Engineering, Electrical Engineering, Mechanical Engineering, or Chemical Engineering
Thorough understanding of industry standards and best practices for computer system validation such as GAMP 5.
Strong understanding of System Validation Life Cycle, testing, and QA methodologies.
- Industrial Controls
- Life Sciences
- Relational Database Systems
Applicants must be authorized to work in the U.S.
CyberCoders, Inc is proud to be an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.
Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.