Pharmaceutical Systems Automation & MES Manager
- (Perm)
- Onsite; Then 3 Days Hybrid Onsite
- CO Leading Pharmaceutical Contract Development/Manufacturer seeks a permanent Pharma Systems Automation & MES Manager onsite in Northeastern Colorado.
This will go to a 3-day Onsight hybrid schedule once individual is fully acclimated. The ideal candidate will have a minimum of 8+ years' total industry experience with 2+ years management. Additionally, this individual will possess hands-on expertise deploying DCS, PLCs, HMIs, and MES Lab Systems with hands-on programming in Visual Basic, and SQL. Ideal candidate will have a proven track record managing digital assets in an efficient and compliant manner, while conducting all managerial responsibilities in accordance with organizational policies, regulatory compliance, and other applicable laws. This person will also be performing daily leadership of team, training, and employee development. Opportunity offers competitive base compensation and benefits within an eventual hybrid perm role. Benefits Base compensation ranges from $165K to $185K . 3-week PTO for first year. 401K with employer matching 100% of first employee contributed 6%. Health, Dental and Vision Benefits (PPO/HSA) Critical Illness, Disability, Life, Insurance Flex Spending Account Paid Parental Leave Tuition Reimbursement Requirements USC or GC Holder; located and resides in the US. BS in Life Sciences or similar area. Ability to reside locally to the client and be on site initially 5 days a week; eventually 3. 8+ years life sciences with 2+ management including contract resources. Hands-on expertise in deployment of Distributed Control Systems (DCS), PLCs, HMIs, and MESs. Hands-on proficiency in Visual Basic, SQL Scripting, and basic Active Director Administrative expertise. Experience in virtualized software like VMWare and client-server experience (TCP/IP, DNS, DHCP, etc.). Prior knowledge of Windows environment and familiarity with VMWare. Proven success in implementing advanced Critical Operational Technology (OT) in regulated environments. Ability and history of interpreting electrical and Piping & Instrumentation Diagrams (P&IDs). Knowledge of electrical controls principles, methods, and standards. CAPEX scope, schedule, and budget processes. Demonstrated mechanical expertise having core knowledge of chemistry, chemical processes and theories, and applications, equipment, and plant operations. Expertise validating various manufacturing processes, while applying risk-based approaches to validation. Familiarity with lean manufacturing, Six Sigma, and continuous improvement. Proven history of leadership while being able to influence and drive change management to effectively manage culture changes, and deployment of Enterprise solutions. Expertise having applied scientific problem-solving methods and extensive analytical and troubleshooting. Responsibilities Providing leadership to various employees while working with other site leaders to effectively manage assets within a compliance and efficient manner. Leading teams, training, and employee development daily to include conducting interviewing/hiring, managing time/attendance, performance reviews, and disciplinary action, and resolving daily problems and conflicts. Developing and executing plant-wide Operational Technology (OT) strategies and roadmaps, in alignment with long-term business objectives and targets. Evaluating, selecting and deployment advanced automation technologies that include robotics, MES, DeltaV, PAT, historian solutions, reporting and more. All to improve the environment and systems quality, safety, and functionality. Helping drive the adoption of all new/existing systems while managing multi-year expense budgets, timelines, and cross-functional teams. Assisting with Technical Ops Management in CAPEX planning to properly deploy OT solutions throughout multiple sites and within capital projects. Defining KPIs, dashboards, and governance of frameworks for program tracking. Collaborating with leadership and other staff to ensure achievement of project goals on time and in budget. Overseeing and supporting user training for organizational OT Systems. Ensuring daily performance support for Pharma Automation Systems which includes preventative maintenance, and technical support and troubleshooting. Managing technical problem/resolution for organizational OT networks and other process contract infrastructure. Managing validation of newer OT applications like CVS and validated state system maintenance. Coordinating and executing continuous improvement throughout the implementation of new equipment, technology, processes, and materials. Providing vendor project execution and coordination, also with internal and external talent. Reviewing and drafting equipment drawings, electrical diagrams, system manuals, engineering protocols, and quality systems documents. As SME, ensuring accountability in support during internal/external regulatory and client audits. Maintaining documentation like functional specs, validation protocols, and change controls. Providing improvements regarding nonconformance, implementing corrective & preventative actions, and executing Commissioning and Qualification activities.
