Technical Operations Manager

Technical Operations Manager for Validation 4.0

At JSat Automation we believe that by providing our customers with the resources they need to overcome obstacles in their quest for scientific discovery and change, we can more broadly improve the daily lives of everyone in our world. It is our mission to provide our clients with a strategic, efficient cost-effective approach to implementation of their projects. Our goal is more than to just deliver a solution but to foster a long-term relationship as a technical partner and to invest in their continued success. Our highly diverse and talented team of engineers, project managers and process specialists are encouraged to channel their passion, innovation, and leadership to help enable us to provide unique, superior turnkey solutions for our customers. We are dedicated to finding the best person for every role at JSat because the solutions and tools that we develop together will help revolutionize numerous industries. If you think you have what it takes, but don't necessarily meet every single point on the job description, please still get in touch. We'd love to have a chat to see what skills/experience you are able to bring to this team.

JSat Automation is hiring a Technical Operations Manager for Validation 4.0. This position will be a management position leading a specific or combination of Engineering departments along with the day-to-day engineering tasks the Technical Operations Manager is responsible to drive Validation 4.0, plan projects, establish project criteria, coordinate project reviews, and ensure the proper implementation 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 complete approved 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 executing company technical processes from beginning to end.

• Provide facilitation, leadership, mentoring and coaching to enhance the team's general capability.

• Effectively direct and deploy resources that support client and customer requirements for the delivery of services.

• Oversee administrative and operational processes that ensure the right engineers are available to 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 in respective field of interests (Automation, Validation, IT, etc.).

• Interact with client personnel to identify and analyze continuous improvement through system upgrades, studies, collaboration, etc

• Drive digital innovation & automation and new ways of working with progressive technologies and platforms.

• Actively participate in the deployment and support of above-mentioned technologies and platforms by collaborating with cross-functional teams.

• Apply a structured agile methodology for system changes and support change management activities.

• 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's are for automation, facilities, utilities, and process.

• Prepare/Author Qualification and Commissioning Protocols.

• Perform Testing, collects samples, analyzing test results, and prepares Commissioning and Qualification summary reports.

• Plan, perform and coordinate Installation Qualification (IQ), inclusive of test generation and execution.

• Peer Reviews Validation Protocols, Commissioning Test and Design documents.

• Provide technical assessment and validation review/approval for engineering, process and standard operating procedure changes.

• Manage or support projects as the primary controls resource.

• Prepare Risk Management Reports documenting system risks, applicable remediation/risk reduction and critical controls.

• Provide input and continuous improvement recommendations to commissioning / qualification protocols.

• Lead and manage development of accurate completion of all commissioning and qualification documentation and Engineering TOPs to ensure that such documents are properly documented and 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 job responsibilities (i.e. Validation Field Execution)

Requirements

• 6 + years of direct GMP/validation experience with increasing levels of responsibility for protocol generation, execution and planning of wide range of validation equipment and software.

• 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, and principles in the advancement of process improvements and complex project execution

• Solid understanding of job financial reporting with ability to apply cost control measures for projects

• 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, quality systems, engineering design fundamentals, regulatory agency expectation and industry trends.

• Tactical thinker with experience working with customers developing testing, validation and/or quality 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.