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General Description:

The Director, Process and Automation Engineering is responsible for leading the strategy, development and implementation of automation technologies and digital solutions across manufacturing at Hopewell. The role focuses on improving process efficiency, ensuring compliance with strict regulatory standards, and leveraging technology to accelerate drug manufacturing. Reporting to this role is Automation, and Manufacturing Technology. This role will be based in Hopewell, NJ and report to the Site Senior Director Facilities and Engineering.

Essential Functions of the Job:

+ Strategic leadership – Develop and execute the sites long-term automation and digital roadmap, ensuring alignment with the overall business goals for operational excellence and innovation. Provide support to manufacturing and facilities teams in areas of deviation/root cause analysis and regulatory inspections.

+ Digital leadership – Champion and drive Data Integrity, digital transformation and Factory of the Future initiatives at the site. Partner with Global Technology solutions to ensure right fit for manufacturing.

+ Project Oversight – Manage the planning execution and completion of complex automation and process related projects, ensuring they are delivered on time, within budget and to the required quality standards.

+ Process Optimization – Identify high-volume or error prone processes suitable for automation. Spearhead initiatives to enhance productivity, cost efficiency and compliance by redesigning workflows and implementing solutions like eBR, eLogs, etc..

+ Technical Transfer experience including equipment qualification, process validation, and computer system validations.

+ Hands-on experience with modification of DCS, PLC, HMI/ SCADA software applications and equipment used in the manufacturing related to cell culture, purification, filling, packaging and OSD.

+ Participate and lead in controls fault or process fault analysis and remediation.

+ Vendor management – Develop and maintain relationships with external vendors and partners to identify, evaluate and implement new technologies and solutions.

+ Requires working in an industrial manufacturing environment including gowning, GMP, and strict regulations.

+ Collaborate and work closely with Automation teams at other sites in China.

+ The ability to operate self-sufficiently and to motivate oneself is crucial for the success of this position. In addition, the ability for this person to develop and maintain transparent communication between departments is essential.

+ Any other assignments as determined by supervisor.

Education / Experience Required:

+ Bachelor’s degree and 10+ years of biological process and automation in GMP manufacturing experience required

+ Master’s degree and 8+ years of biological process and automation in GMP manufacturing experience preferred

Supervisory Responsibilities:

+ 6+ years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

+ This role will build and lead a high-performing team of automation engineers and process engineers. This includes providing mentoring, coaching, and career development to foster a culture of technical expertise.

Computer Skills:

+ Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

+ Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV). (6+ years)

+ Strong experience with one or more of the following platforms: Rockwell DCS, DeltaV, Allen Bradley PLC, OSISoft PI historian, Siemens, Instrumentation and control panel hardware as required by the job.

+ Strong experience with process and equipment design, change management, process and equipment validation.

+ Direct project management experience required.

Other Qualifications:

+ Exposure to or direct experience with regulated environments (i.e. cGMP, OSHA, EPA).

+ Previous experience in a manufacturing or operations environment.

+ Experience authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents.

+ Experience in managing small to medium-sized projects and outside vendors. Effective written and verbal communications skills.

+ Project management experience (5+ years)

**Travel:** Up to 10% (Project related)

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.