US_East | Manufacturing & Process Engineer_L

Position: US_East | Manufacturing & Process Engineer_L2
Description:

"Possible 3 Month CTH | No Fees | Do Not Re-Post| Confidential

TMR
Role:
Senior Digital Engineer - PAS-X Expert

Work location:

Barceloneta, Puerto Rico
Background and Meet and Greet: MANDATORY

Job Description:

As a Senior Digital Engineer you will play a critical role in the design, implementation, and maintenance of our automation systems, specifically using Werum PAS-X. You will lead automation projects, ensuring compliance with industry standards and regulations while optimizing production processes. This role is ideal for an automation expert with a minimum of 10 years of experience in the pharmaceutical industry, who is ready to take on a challenging and rewarding position.

Key Responsibilities:

"
• Werum PAS-X Implementation:
Lead and manage the design, configuration, and implementation of Werum PAS-X systems to ensure seamless integration with existing pharmaceutical manufacturing processes.

• Project Leadership:
Take charge of automation projects, from inception to completion, ensuring adherence to project timelines and budget constraints.

• Compliance:
Ensure all automation processes comply with industry regulations, including GMP (Good Manufacturing Practices) and FDA guidelines.

• System Maintenance:
Oversee the maintenance, troubleshooting, and optimization of Werum PAS-X systems to ensure maximum uptime and operational efficiency.

• Validation:
Manage the validation and qualification processes for automation systems, ensuring they meet industry standards and regulations.

• Documentation:
Maintain comprehensive documentation of automation processes, including SOPs (Standard Operating Procedures) and change control documentation.

• Training:
Provide training and support to colleagues and team members to ensure their proficiency in Werum PAS-X systems.

• Continuous Improvement:
Identify opportunities for process optimization and efficiency improvements within the automation systems and propose solutions.
"

What are the Mandatory skills and skill proficiencies required for this position?
"
• Minimum of 10 years of experience in the pharmaceutical industry with a focus on automation and Werum PAS-X systems. (5)

• Strong knowledge of GMP, FDA regulations, and industry best practices. (5)

• Proficiency in Werum PAS-X and other pharmaceutical automation systems. (5)

• Project management experience, with the ability to lead cross-functional teams. (4)

• Excellent problem-solving skills and the ability to work effectively in a team-oriented environment. (4)

• Strong communication and documentation skills. (3)

• Bachelor's degree in engineering, Computer Science, or a related field. (3)
"

The following details must accompany your submission:

First Name, Middle name, and Last Name:
City and State:
Open to Relocate?
Rate:
Availability:
Phone #:
Mobile #:
Email address:
Visa type:
Visa Expiration Date:
Hiring Status:

Soemia Pineda - ERM
Capgemini North America
Tel.: "

Additional Details

• Global Grade : B
• Named Job Posting? (if Yes - needs to be approved by SCSC) :
  No
• Remote work possibility :
  No
• Global Role Family : 61404 (P) Manufacturing & Process Engineering
• Global Technical Skills Family : 18611 (F) Product Engineering
• Local Role Name :
  Senior Digital Engineer - PAS-X Expert
• Local Skills :
  Julie Skidmore
• Languages
  
  Required:
  
  :
  English