Senior Manufacturing / Process Engineer

Job Title

Senior Manufacturing / Process Engineer

Requisition

JR000015860 Senior Manufacturing / Process Engineer (Open)

Location

Port Allen, LA

Additional Locations

Job Description Summary

This position provides technical leadership and hands-on engineering support for pharmaceutical manufacturing operations. Responsibilities include execution of capital projects, process / system engineering support / design, and general engineering support in a cGMP-regulated environment. The role combines project management, technical design, and process optimization, with opportunity to grow into broader engineering leadership responsibilities.

Position is cross functional and includes pharmaceutical drug (Ultra High Purity (UHP) compressed gas parental products), Device Engineering, Validation, Business Development, R&D / new product commercialization, Quality Assurance, Risk Management, Regulatory Affairs, HSE and Maintenance.

The position requires a self-starter with solid engineering expertise ranging from product/process conception through post commercialization activities and sustainment. The position will provide technical and project management support to include establishment of policies, SOPs, best practices, interdepartmental needs assessment and inclusion, team selection, project scoping, project tracking, leading status meetings, risk assessment, evaluating and reporting project progress, conflict resolution and post project reviews.

Job Description

Key Responsibilities:

• Manage capital and improvement projects including scope, schedule, budget, and execution
• Provide process engineering support including troubleshooting, root cause analysis, and continuous improvement
• Develop and maintain engineering documentation (P&IDs, PFDs, electrical drawings, equipment files)
• Support Manufacturing, Quality, Validation, R&D, and Business Development
• Coordinate equipment modifications and installations including design and risk evaluation
• Manage vendors, contractors, and engineering service providers
• Perform field walkdowns and ensure documentation accuracy
• Develop and maintain engineering standards, SOPs, and best practices
• Support site capital planning and long-term engineering strategies
• Other project activities that may be assigned by Management.

Minimum Requirements:

• Bachelor’s degree in engineering or relevant life sciences discipline.
• 5+ years of engineering experience in manufacturing or regulated industries
• Experience with capital projects and process engineering
• Strong technical problem-solving and project execution skills
• Ability to manage multiple priorities and deliver results
• Demonstrated ability to lead and influence others to achieve outcomes.
• Ability to effectively manage internal and external relationships and expectations.
• Ability to effectively guide and lead teams to achieve desired results within timelines and budget commitments.

Preferred Qualifications

• Thorough knowledge of the pharmaceutical drug commercialization process and team-based matrix management.
• Experience with medical device manufacturing.
• Experience in Ultra High Purity (UHP) industrial gas organizations.
• Working knowledge of cGMPs, including hands-on experience with their interpretation and practical application.
• Experience applying Risk Analysis Principles in validation or quality activities.
• Proficiency with Microsoft applications (Word, PowerPoint, Excel, Outlook)
• Skills that will contribute to success:
  • Experience working with high purity gases under high pressure and vacuum
  • Experience with development / support of automated systems and equipment
  • Expertise / experience working with Rockwell control solutions (RSLogix, Factory Talk, VFDs, etc)
  • Effective time management
  • Strong technical writing capabilities
  • Ability to lead or deliver presentations
  • Lean Manufacturing Training or experience

Relationship with Others/Scope of Position:

• Develop and manage Vendors/Architectural & Engineering Firms/Consultant contract agreements and interactions ensuring capital project deliverables meet project design objectives & deliverables in compliance with cGMP requirements
• Effectively communicate with individuals at all levels of responsibility within the various organizational levels within the facility and external.

Keenova offers employees a Total Rewards package which includes competitive pay and benefits. To learn more about our Total Rewards benefits please visit: Keenova Careers | Serve and Grow with Purpose | Keenova

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support-showing up in big moments and small to help patients find comfort and confidence.

We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.

We are Keenova-keen to solve, keen to serve. Learn more at www.keenova.com.