Manufacturing Director jobs in Everett, WA

We are an EasyHiring recruiting company that is looking for candidates for our partners for the position of Associate Director MSAT Automation & Manufacturing Systems in Washington - Larch Way for work in Washington - Larch Way

PURPOSE AND SCOPE OF POSITION (Position Summary):

This position will be responsible for controls systems design, programming, simulation and testing, validation, troubleshooting, and project documentation. Equipment planned for automation control includes bioreactors and media processing system. Position will include participating in initial qualification activities (CSV, recipe qualification) and ongoing activities such as recipe revision, periodic review, validation, and integration with MES and data historian.
This position will work with global teams to design automated solutions that improve processes and integrate new equipment. The Automation Engineer III role will represent site automation in cross functional efforts and work collaboratively with system owners and quality groups.

QUALIFICATION REQUIREMENTS (Knowledge, Skills and Abilities):

Education:

• BS in engineering, computer science, biology, or equivalent scientific discipline.

Experience:

Basic Qualifications:

• 8 years relevant biopharmaceutical industry experience.
• 5 years of automation system experience is strongly preferred.
• 4 years managing teams
• Experience with Emerson Delta V batch processing.
• Experience with cGMP/GMP, ICH guidelines, date integrity, computer system validation, safety principles, and working within a regulated industry.

Preferred Qualifications:

• Experience with biopharmaceutical manufacturing, cell culture.
• Experience with defining class-based modules.
• Experience configuring and testing phase logic and sequence flow charts.
• Experience with control and equipment modules, state driven algorithms.
• Experience using DeltaV Operate (Live) to configure graphics.
• Experience with VBScript and PSSB library.
• Knowledge of industrial network buses (Fieldbus, DeviceNet, Profibus)
• Demonstrated leadership of multidiscipline, high-performance work teams/groups including the ability to navigate a heavily matrixed organization
• Demonstrated ability to represent site strategy on global teams
• Excellent written, verbal, and presentation skills.
• Ability to work with users to clearly define written requirements.
• Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
• Capable of adapting to rapidly changing priorities and deadlines.

Licenses/Certifications:

• N/A

ROLES AND RESPONSIBILITIES:

• Lead a team of automation engineers working with in the Emerson Delta V platform for both established recipes and introduction of newly automated equipment.
• Mentor and motivate direct reports as well as cross-functional teams to deliver results under demanding timelines and situations
• Build a collaborative environment that fosters decisive decision making and accountability
• Create an environment of teamwork, open communication, and a sense of urgency
• Ensure seamless operations and quality support through identifying and solving cross-functional and inter-team challenges
• Design automation strategies in Emerson Delta V by defining class-based modules, using sequence flow charts, phase logic modules, and creating process operator graphics.
• Work with Facilities & Engineering, and IT groups to implement new field networks and commission new units.
• Collaborate and represent Bothell site interests with internal and global functions (Process Development, Computer System Validation, Quality) to translate requirements into automated solutions.
• Adhere to software development lifecycle (SDLC) practices and S88 automation standards.
• Author, review, and perform recipe validation.
• Maintain qualification/validation documentation (protocols, reports, schedule).
• Partner with key stakeholders to define system requirements and identify risk.
• Meet control strategies based on functional specifications, existing code, and operator input.
• Provide automation impact assessments for process and material changes.
• Provide installation and start up support for projects as needed. Start up support includes but not limited to installation consulting, loop check support, startup assistance, loop tuning, and configuration modifications.
• Represent automation programs during regulatory inspections.
• With IT, deliver integrated solutions across multiple platforms including Delta V, Emerson Syncade, data historian, and benchtop equipment.
• Implement and maintain risk assessments that ensure process controls address known risks.
• Provide training for system use, troubleshooting, and recipe maintenance to manufacturing and other groups.
• Interact with end users, IT, maintenance, and support groups while troubleshooting issues.
• Request quotes from vendors for approved equipment, software and services.
• Identify and implement continuous improvement, efficiency, and system reliability projects.

Job Type: Full-time

Work Location: On the road