Location: Muskegon, MI (Onsite)
Experience – 13 years
JD
Role Responsibilities:
· Technical ownership for the project
· Act as the primary automation representative in cross-functional program leadership meetings, ensuring alignment between automation, process engineering, digital/MES, and quality teams
· Serve as the key point of contact for client stakeholders and senior leadership regarding automation scope, progress, and risk mitigation
· Collaborate with Program technical offices to ensure the automation solution is aligned with the overall program automation philosophy and standards
· Provide technical leadership to the multiple area leads working on their project for the respective area/node and ensure that applicable standards are followed
· Collaborate with project managers to define automation budgets, resource needs, and vendor engagement strategies.
· Ensure consistency of the automation deliverables (requirements, functional specifications, control strategies, phases, and recipes, etc.)
· Participate in P&ID and lead control strategy design
· Lead in defining the software components that need to be created or modified
· Communicate progress, issues, and needs to automation project manager for the entire workstream/all areas
· Lead input, review, and approve of functional requirements and specifications
· Lead design of Parameter and Recipe Specification philosophy
· Responding to system integrator technical queries
· Lead and collaborate on the development of software testing strategies
· Identification of any remediation effort required on process control software
· Identify and analyze risks of technical nature particular to the area and planning responses
· Maintain compliance with training requirements
· Provide training and support to junior engineers and other team members.
· Champion the adoption of emerging technologies, tools, and methodologies that improve automation efficiency, reliability, and maintainability.
Requirements:
· Bachelor’s degree in Engineering or equivalent experience.
· 12+ years of automation experience in the pharmaceutical industry, with a strong preference for API/bulk manufacturing environments.
· Proven experience leading cross-functional automation teams on large-scale pharmaceutical projects or programs.
· Demonstrated ownership of full project lifecycle from design through commissioning and validation.
· Deep expertise in DeltaV DCS, including architecture, configuration, and deployment.
· Experience with other OT systems is a plus.
· Strong understanding of GMPs, regulatory compliance, and computer system validation (CSV) principles.
· Excellent communication skills, with the ability to influence stakeholders at all levels.
· Experience in mentoring and developing junior engineers and technical leads.
· Ability to manage multiple priorities and stakeholders in a dynamic project environment.
SKILLS
· Strategic thinker with a proactive and ownership-driven mindset.
· Strong leadership and team-building capabilities.
· Skilled in cross-functional collaboration, especially with MES, digital, and process engineering teams.
· Advanced problem-solving and risk management skills.
· Demonstrated ability to define and enforce technical standards across teams.
· Proficient in writing and reviewing protocols, specifications, and validation documents.
· Experience with issue tracking systems and managing remediation efforts.
· Ability to drive continuous improvement and innovation in automation practices.
· Comfortable presenting to executive stakeholders and facilitating technical workshops.
· Strong organizational skills with the ability to prioritize and delegate effectively.
Required Qualifications
· Bachelor’s or Graduate degree in Engineering (Chemical, Electrical, Computer) or equivalent experience.
· Minimum 12 years of hands-on automation experience in the pharmaceutical or biopharmaceutical industry, with a strong focus on DeltaV platform implementation.
· Proven experience leading process automation projects in regulated Pharma/Biotech environments.
· Strong understanding of ISA-88 batch control standards and GAMP guidelines.
· Deep familiarity with the Software Development Life Cycle (SDLC) and Agile methodologies in automation contexts.
· Demonstrated ability to lead cross-functional teams, mentor engineers, and drive technical decision-making.
· Clear understanding of automation compliance requirements, including GMP and validation principles.
· Excellent communication skills with the ability to collaborate across engineering, quality, and digital/MES teams
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