Sr Project Manager II (Engineering and Automation)

$134,600 - $144,600/Yr

Balchem - Allentown, PA

Full-time - Senior

Allentown, PA

10,001+ employees

Chemical Manufacturing

About the position

The Sr Project Manager II (Engineering and Automation) at B. Braun Medical, Inc. is responsible for overseeing the development and execution of engineering projects within the pharmaceutical and medical device sectors. This role involves managing project lifecycles, ensuring compliance with industry standards, and optimizing processes to enhance operational efficiency. The position requires collaboration with various teams and external vendors to deliver projects on time and within budget, while also acting as a subject matter expert in automation and control systems.

Responsibilities

• Develop project design, development, controls philosophy, and procedural documents to execute projects to GAMP standards.
• Review drawings, electrical design, technical specifications, and qualification documents to support technical project execution.
• Manage and implement various Historian, Batch, PLC/SCADA projects.
• Analyze existing equipment and processes to identify areas for improvement and recommend solutions.
• Act as a subject matter expert for designated systems and provide technical recommendations.
• Anticipate potential process-related problems and develop contingency plans.
• Perform troubleshooting and modifications to automated equipment adhering to GMP standards.
• Create and modify system specifications and SOPs for supported systems.
• Manage all aspects of project lifecycles including planning, scope definition, design, execution, and delivery.
• Track progress against milestones and prepare reports for senior management.
• Assist with the selection and management of external consultants or vendors.

Requirements

• Bachelor's degree required, Master's degree preferred.
• 10-12 years of related experience required.
• Experience with plant floor/Manufacturing Execution Systems (MES) solutions is a must.
• Knowledge of FDA, EU, and global GMPs including Good Automated Manufacturing Practices is required.
• Validation experience in the Life Science / Pharmaceutical industry is required.
• Ability to use a broad range of software used in the Pharmaceutical industry (e.g., MS Office, MS Project, AutoCAD, SAP, SQL).
• Requires advanced knowledge of professional field and industry.

Nice-to-haves

• Applicable industry/professional certification preferred.
• Experience with FactoryTalk Production Centre, PharmaSuite, LabWare LIMS, and OSI PI-Historian is highly desirable.
• Experience with .NET technologies preferred.

Benefits

• Healthcare coverage
• 401(k) plan
• Tuition reimbursement