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At JSat Automation we believe that by providing our customers with the resources they need toovercome obstacles in their quest for scientific discovery and change, we can more broadlyimprove the daily lives of everyone in our world. It is our mission to provide our clients with astrategic, efficient cost-effective approach to implementation of their projects. Our goal is morethan to just deliver a solution but to foster a long-term relationship as a technical partner and toinvest in their continued success. Our highly diverse and talented team of engineers, project managers and process specialists areencouraged to channel their passion, innovation, and leadership to help enable us to provideunique, superior turnkey solutions for our customers. We are dedicated to finding the best personfor every role at JSat because the solutions and tools that we develop together will helprevolutionize numerous industries. If you think you have what it takes, but don't necessarily meetevery single point on the job description, please still get in touch. We'd love to have a chat to seewhat skills/experience you are able to bring to this team. Apply Today to find out how you can joinJSAT Automation and make an impact
Sat Automation is hiring a Technical Operations Manager for Validation 4.0. This position will be amanagement position leading a specific or combination of Engineering departments along with theday-to-day engineering tasks the Technical Operations Manager is responsible to drive Validation4.0, plan projects, establish project criteria, coordinate project reviews, and ensure the properimplementation of project elements. Assist with the scheduling, planning, forecasting, resourcing,and managing technical activities to ensure project accuracy and quality.
• Manage the activities of on-site project resources; define detailed plan necessary to completeapproved projects on schedule and within budget; support testing and commissioning activities;ensure the deliverable is technically and functionally correct.
• Responsible primarily for planning, coordinating and excuting company technical processes from beginning to end.
• Provide facilitation, leadership, mentoring and coaching to enhance the team's generalcapability.
• Effectively direct and deploy resources that support client and customer requirements for thedelivery of services.
• Oversee administrative and operational processes that ensure the right engineers are availableto successfully complete scheduled and specialty project requests.
• Ensure compliance with industry standards in cGMP environment.
• Lead a team of engineers in the designing, development, installation and support of systems inrespective field of interests (Automation, Validation, IT, etc.).
• Interact with client personnel to identify and analyze continuous improvement through systemupgrades, studies, collaboration, etc
• Drive digital innovation & automation and new ways of working with progressive technologiesand platforms.
• Actively participate in the deployment and support of above-mentioned technologies andplatforms by collaborating with cross-functional teams.
• Apply a structured agile methodology for system changes and support change managementactivities.
• Maintain/develop strong relationships with stakeholders to facilitate successful collaborations.
• General Commissioning, Qualification and Validation (CQV).
• Oversight of Change Records, which includes CR generation through tracking CR closure. CR'sare for automation, facilities, utilities, and process.
• Prepare/ Author Qualification and Commissioning Protocols.
• Perform Testing, collects samples, analyzing test results, and prepares Commissioning andQualification summary reports.
• Plan, perform and coordinate Installation Qualification (IQ), inclusive of test generation andexecution. • Peer Reviews Validation Protocols, Commissioning Test and Design documents.
• Provide technical assessment and validation review/ approval for engineering, process andstandard operating procedure changes.
• Manage or support projects as the primary controls resource.
• Prepare Risk Management Reports documenting system risks, applicable remediation/ riskreduction and critical controls.
• Provide input and continuous improvement recommendations to commissioning / qualificationprotocols.
• Lead and manage development of accurate completion of all commissioning and qualificationdocumentation and Engineering TOPs to ensure that such documents are properly documentedand complete.
• Incorporate commissioning protocol execution with process testing and debugging activities.
• Accountable for Project-specific:

• Design Qualification
• System Impact Assessments (SIA's)
• Criticality Assessment (CA's)
• Risk Assessment (RA's)
• Requirements Trace Matrices (RTM's)
• Design Verification o Commissioning and Commissioning Test documentation
• Instrument Calibration assessments
• Operational Qualification and Process Qualification 1 (process support systems)documentation creation, execution, and summary reports

• Provide C&Q support and updates for:

• User Requirements Specifications (URS)
• Functional Specifications (FS)
• Automation Functional Requirements (AFR)
• Functional Batch Record Review (FBRR)

• Lead validation planning and execution efforts
• Participate in FAT and manage SAT executions.
• Project closeout activities.
• Attend any project specific meetings as assigned.
• Maintain all required training to ensure job responsibilities can be performed daily.
• Vigilant to safety and maintains a safe environment for all during performance of jobresponsibilities (i.e. Validation Field Execution)
Requirements
• 6 + years of direct GMP/ validation experience with increasing levels of responsibility forprotocol generation, execution and planning of wide range of validation equipment andsoftware.
• Clear, strategic thinker with vision, with the ability to execute on priorities
• Must have strong project management skills (Scheduling, Budgeting, & Resourcing)
• Experience managing proposal creation processes.
• Excellent verbal, written and presentation skills
• Attention to detail, accuracy, and proactive relevance to company interests
• Experienced in the application of engineering best practice, methodologies, tools, software, andprinciples in the advancement of process improvements and complex project execution
• Solid understanding of job financial reporting with ability to apply cost control measures forprojects
• Excellent analytical and organizational skills.
• Experience with automation, commissioning, qualification, or operations in a cGMP environment. • Knowledge of current industry standards such as GAMP5 and ASTM E2500.
• Experience in Computer System Validation (CSV) for manufacturing systems.
• Experience with Emerson DeltaV, Emerson Syncade and Pi software preferred.
• Proficient/ thorough knowledge of validation of principles, manufacturing processes, qualitysystems, engineering design fundamentals, regulatory agency expectation and industry trends.
• Tactical thinker with experience working with customers developing testing, validation and/orquality strategies.
• Strong technical writing, verbal communication, interpersonal and problem-solving skills.
• Ability to work independently.
• Strong computer skills and familiarity with Microsoft office suite programs.
• Compliance to cGMP requirements.
• Demonstrate good record keeping practices and attention to detail.
• Excellent client communication skills.
• Excellent collaboration and ability to communicate information to a varied audience
Benefits
Salary DOE: The pay range for this position is $120k - $160k per year; however, base pay may be higher or lower depending on the candidate's job-related knowledge, skills, and experience. This figure does not include additional compensation such as health benefits, PTO, etc..