Qualifications:
B.S. in Engineering/Science or equivalent experience - 4 or more years of industry experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA. - Experience in writing and execution of IQ, OQ, and PQ forms and protocols for GMP Utilities, Equipment, Systems, and Software. - Proficiency with Microsoft Office applications. - High level of knowledge of P&IDs and instrumentation/control equipment. - Experience with DeltaV, UNICORN, and/or other control software is beneficial. - Experience with Risk-Based Approach to Commissioning and Qualification is beneficial.
Responsibilities:
Performs cGMP compliance based activities (commissioning, qualification, validation, etc.) as developed and defined by department procedures. - Follows internal engineering standards and requirements, overall good industry practices and regulatory requirements. - Generates and reviews calibration and preventative maintenance documentation. - Prepares necessary documents for production use, such as SOPs and Job Aids. - Prepares and performs engineering studies as needed. - Analyzes data to determine solutions for issues, questions, or encountered problems. - Highly independent with excellent time management. - Able to demonstrate excellent oral communication skills, deductive reasoning skills, and problem sensitivity. - Able to independently manage, prioritize, problem-solve, and be successful in dealing with staff at all levels of the organization.
B.S. in Engineering/Science or equivalent experience - 4 or more years of industry experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA. - Experience in writing and execution of IQ, OQ, and PQ forms and protocols for GMP Utilities, Equipment, Systems, and Software. - Proficiency with Microsoft Office applications. - High level of knowledge of P&IDs and instrumentation/control equipment. - Experience with DeltaV, UNICORN, and/or other control software is beneficial. - Experience with Risk-Based Approach to Commissioning and Qualification is beneficial.
Responsibilities:
Performs cGMP compliance based activities (commissioning, qualification, validation, etc.) as developed and defined by department procedures. - Follows internal engineering standards and requirements, overall good industry practices and regulatory requirements. - Generates and reviews calibration and preventative maintenance documentation. - Prepares necessary documents for production use, such as SOPs and Job Aids. - Prepares and performs engineering studies as needed. - Analyzes data to determine solutions for issues, questions, or encountered problems. - Highly independent with excellent time management. - Able to demonstrate excellent oral communication skills, deductive reasoning skills, and problem sensitivity. - Able to independently manage, prioritize, problem-solve, and be successful in dealing with staff at all levels of the organization.