Sr Project Manager II (Engineering and Automation)

About B. Braun

B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap and CAPS.

Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.BBraunUSA.com.

Position Summary:

Responsibilities: Essential Duties

• Responsible for developing project design, development, controls philosophy, procedural documents, RFQ to execute projects to GAMP standards.
• Review drawings, electrical design, technical specifications, FAT/ SAT/ qualification documents to support technical projects execution.
• Develops, manages, and implements various Historian, Batch, PLC/SCADA projects.
• Analyze existing equipment, processes, facilities, infra structure and systems to identify areas of improvement and recommend solutions to optimize performance.
• Acts as a SME for designated systems/ technologies and provide technical recommendations.
• Anticipate potential process related problems, risks and technical conflicts and develop the necessary contingency plans to improve business continuity.
• Performs troubleshooting and modifications to the automated equipment adhering to Pharmaceutical and Medical Devices GMP change control standards and policies.
• Creates and modifies system specifications and SOPs for the systems supported.
• Performs administrative, upgrades and maintenance tasks for equipment/ control systems
• Manages all aspects of projects for the organization.
• Coordinates the work activities for multiple functions to ensure satisfying delivery.
• Responsible for all aspects of the project lifecycle: planning, scope definition, design, execution and delivery.
• Tracks progress against milestones, budgetary guidelines or other performance indicators, and prepares reports to senior management.
• Assists with the selection, negotiation and managing of all activities regarding external consultants or vendors. Must build collaborative relationships.
• Must have ability to identify and seek needed information/research skills, project scheduling skills and project management skills.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

Expertise: Knowledge & Skills

• Ability to use a broad range of software used in the Pharmaceutical industry (e.g. MS Office applications, MS Project, MS Visio, AutoCAD, SAP, SQL etc.)
• Ability to take initiative and make decisions demonstrating leadership in job performance, while promoting teamwork by participating as a team player with effective communication skills.
• Deployment experience with plant floor/Manufacturing Execution Systems (MES) solutions (e.g. Rockwell ProPack Data, Werum PAS-X, POMS) is a must.
• Experience with FactoryTalk Production Centre, PharmaSuite, LabWare LIMS, and OSI PI-Historian is highly desirable. Automation Software experience with RSLogix 5000, PlantPAx , FactoryTalk Batch, Siemens PCS 7 , Siemens OpCenter MES are helpful. Also, Experience with .NET technologies preferred.
• Knowledge of FDA, EU, and global GMP's including Good Automated Manufacturing Practices, 21 CFR Part 11, and EU cGMP Annex 11. Relevant Quality education or training within ISO 9001 and cGMP is highly preferred.
• Validation experience in the Life Science / Pharmaceutical industry required. Ensure that the system remains in a validated state and that proper change control practices are followed. The MES Engineer will also act as the primary contact for Regulatory Compliance internal and external audits.
• Experience integrating ANSI/ISA-88 and ANSI/ISA-95 standards where the MES is integrated into the Batch Execution System (BES)
• Knowledge of SAP Material Master (MM), Production Planning (PP), Production Planning for the Process Industry (PP/PI) and Quality Management (QM) modules.
• Requires advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, concepts. Determines best course of action.
• Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training , assigning and checking the work of lower level employees. Referring only complex problems and issues
• Judgement is required in resolving complex problems based on experience.
• Contacts are primarily with department supervisors, leads, subordinates, and peers. Frequent contact with external contractors/vendors.

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.

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Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• Bachelor's degree required, Master's degree preferred.
• 10-12 years related experience required.
• Applicable industry/professional certification preferred.
• Regular and predictable attendance
• Occasional business travel required, Ability to work non-standard schedule as needed

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

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Responsibilities: Other Duties:

The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

Physical Demands:

While performing the duties of this job, the employee is expected to:

• Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.

Lifting, Carrying, Pushing, Pulling and Reaching:

• Occasionally:Reaching upward and downward, Push/pull
• Frequently:Stand, Sit
• Constantly:N/A

Activities:

• Occasionally:Handling, Push/pull, Reaching upward and downward, Walking
• Frequently:Hearing - ordinary, fine distinction, loud (hearing protection required), Sitting , Standing, Talking - ordinary, loud/quick
• Constantly:N/A

Environmental Conditions:

• Occasionally:N/A
• Frequently:Proximity to moving parts
• Constantly:N/A

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Noise Intensity:Moderate
• Occasionally:Production/manufacturing environment, Warehouse environment, Lab environment
• Frequently:Office environment
• Constantly:N/A

Equal Opportunity Employer Veterans/Disabled

PI253687194