Senior Manufacturing / Process Engineer
About The Position
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. This 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.
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.
Nice To Haves
- 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)
- 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
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.
Benefits
- competitive pay and benefits
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What This Job Offers
Job Type
Full-time
Career Level
Senior
