Sr Engineer

Validation &

• Engineering Group Inc V&EG a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the following areas Laboratory Compliance Computer Engineering Project Management Validation and other services We are seeking a talented dedicated individual committed to work under the highest ethics standards for the following position Sr EngineerC&Q Strategy &
• Planning Develop and implement the overall Commissioning &
• Qualification strategy aligned with project and regulatory requirementsDefine system boundaries and identify directindirect impact systemsLead risk assessments eg ISPE Baseline ASTM E2500 to determine qualification scopeDevelop C&Q plans schedules and resource forecastingCommissioning Activities Oversee andor execute commissioning activities including FAT SAT and field commissioningEnsure systems are installed and operate per design specificationsCoordinate with vendors and contractors during startup activitiesReview and approve commissioning documentation and test resultsQualification Execution IQOQPQ Author review and approve qualification protocols IQ OQ PQEnsure traceability from User Requirements Specifications URS through testingExecute or oversee protocol execution and ensure proper documentation of resultsDocumentation &
• Compliance Ensure all C&Q documentation complies with GMP FDA EMA and internal Amgen standardsMaintain document lifecycle within electronic systemsSupport data integrity and ALCOA principles throughout qualification activitiesPrepare and support validation summary reportsRisk Management &
• Change Control Lead and document risk assessments related to system qualificationEvaluate and manage change controls impacting validated systemsAssess impact of deviations and implement corrective and preventive actions CAPACross functional Coordination Collaborate with Engineering Validation Quality Assurance QA Manufacturing and Supply Chain teamsInterface with system owners and technical authoritiesProvide technical guidance and mentorship to junior engineers and project team membersSupport project meetings status reporting and stakeholder communicationCharacterization Process Develop the characterization protocolsExecute the characterization activitiesDevelop and review the characterization reportsFUNCTIONS General 1 Complete complex or novel assignments requiring development of new andor improved engineering techniques and procedures 2 Develop engineering policies and procedures that affect multiple organizational units 3 Supervise coordinate and review work of a small staff of engineers associates andor technicians on an ongoing basis as well as on a project basis 4 Employ advanced engineering techniques andor modifications of advanced techniques within area of engineering expertise 5 Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields 6 Serves as a peer recognized engineering technology specialist in at least one area with overall responsibility for determining methodologies in that area 7 Application of mature engineering knowledge in planning and conducting projects Other functions may be assigned Design Engineering 1 Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity 2 Work with research manufacturing process development utilities facilities quality assurance and validation departments in developing requirements and recommendations for large andor highly complex systemfacility modifications 3 Work with project managers to complete design and engineering projects within schedule budget and quality constraints 4 Coordinate the work of consultants architects and engineering firms on development of standard design documents 5 Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project EDUCATION Masters 2 years of Engineering experience OR Bachelors in Engineering 4 years of Engineering experience COMPETENCIESSKILLS 1 Working knowledge of pharmaceuticalbiotech processes 2 Familiarity with validation processes 3 Familiarity with documentation in a highly regulated environment 4 Ability to operate specialized laboratory equipment and computers as appropriate 5 Ability to interpret and apply GLPs and GMPs 6 Ability to apply engineering science to production 7 Able to develop solutions to routine technical problems of limited scope Demonstrated skills in the following areas Problem solving and applied engineering Basic technical report writing Verbal communication Comprehensive understanding of validation protocol execution requirements Basic technical presentationso Personal Organizationo Validation Protocol Writing Dealing with and managing changeo Technical Equipment Specific Analytical Problem Solvingo Computer Literacy Specialized equipmentprocess expertise In depth knowledge of validation processes and requirements as applied to new equipment installations Interacts effectively with variety of communication and working styles Ability to independently determine when additional internal resources are required to solve problems Ability to handle multiple projects at one time Schedule development to Facilitation Collaboration Basic project managemento Completion and follow up Established expertise in at least 3 separate areas of engineering technology Ability to independently determine when additional external resources are required to solve problems Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach Working knowledge of financial analysis tools Ability to delegate and manage the project work of others At Validation &
• Engineering Group people always come first We believe that when youre empowered to do your best work bold ideas thrive and real progress happens This isnt just a job its an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose driven supportive team Excited to build something meaningful together We look forward to hearing from you Validation &
• Engineering Group is an equal opportunity employer All applicants will be considered for employment without regard to race color religion sex sexual orientation gender identity national origin veteran status or disability status