"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.

Noramco LLC., d/b/a Siegfried Wilmington

GENERAL PURPOSE OF JOB

The position will report to the Director of Operations and will lead a team of Process Engineers. This position manages critical process engineering functions including but not limited to: New Product Introduction (NPI) / Life Cycle Management (LCM) / Technology Transfer coordination at site, Performance Qualification (PQ), Validation Execution (Process and Cleaning Validation), LEAN Process Improvements (identification and execution), commercial production investigations, and Qualification of new raw materials.

ESSENTIAL DUTIES AND RESPONSIBILITIES

· Responsible for the development and leadership of employees in Process Engineering group.

· Provides guidance and work direction to department employees, temporaries, contractors, and coops.

· Communicates business goals and status to direct reports and other company leaders

· Leads and manages in-line production support activities, equipment performance qualification, process transfer, process characterization and verification (including Cleaning).

· Guides, reviews and approves technology and product technical life cycle management documents, process development reports, documentation associated with process validation and production records, validation and transfer, technical protocols, reports, procedures, specifications and regulatory documents.

· Evaluates projects, generating conclusions and provide hand-over documents for business-based decisions.

· Partners with site Engineering, Facilities, and Production on commercial investigations and project execution and oversight.

· Provides technical support and expertise to both internal and external customers such as Production, Regulatory, Quality, EHS and third-party customers and partners.

· Identifies and facilitates improvements and is responsible for ensuring key continuous improvement projects are initiated, approved, and executed in a timely fashion, aligned with internal procedures.

ADDITIONAL POSITION REQUIREMENTS

· May be required to support production operators during introduction of processes/ products.

· Successfully completes regulatory and job training requirements.

· Understands and responsibly performs duties with attention to quality, safety and environmental matters. Items include; wearing appropriate personal protective equipment, recognizing, reporting and appropriately responding to hazards in the work area and maintaining proper housekeeping.

· Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Complies with all company and site policies and procedures.

· Remains current in skills and industry trends.

· Is available for other duties as required.

SUPERVISORY RESPONSIBILITIES

· Supervises the Process Engineering group.

· Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.

· Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

QUALIFICATIONS EDUCATION and/or EXPERIENCE

· Minimum requirements include: BS/MS in chemistry or chemical engineering with 10 plus years of related experience in process engineering, commercial manufacturing, and/or kilo lab/pilot plant and successful transfer of processes to production.

· Experience working directly with commercial manufacturing and quality control laboratories is preferred

· At least 5 years prior experience supervising or managing others preferred

· Strong expertise in pharmaceutical manufacturing processes, products, and manufacturing equipment.

· Strong knowledge of Quality & Compliance and regulatory requirements (GMP/EH&S) required. Employees must adhere to applicable cGxP’s and procedures, all applicable regulatory requirements, and all applicable Safety, Health and Environment (EH&S) and procedures are required.

· Strong experience in project management, organizing, planning and coordination skills

· Demonstrated successful experience with chemical process development, process scale-up and transfer of processes to commercial production

· An ability to lead cross functional team, to manage complexity and change is required and to interact and communicate with different levels of the organization

· Knowledge of process excellence such as Six Sigma, lean concepts and tools, preferred.

LANGUAGE SKILLS

· Read, analyze, and interpret the most complex documents.

· Respond effectively to the most sensitive inquiries or complaints.

· Write presentations and articles using original or innovative techniques or style.

· Make effective and persuasive presentations on controversial or complex topics to top management, public groups, and/or boards of directors.

PHYSICAL DEMANDS

· The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms.

· The employee must occasionally lift and/or move up to 10 pounds.

· Specific vision abilities required by this job include close vision, and distance vision.

· Must be able to qualify for respiratory protective equipment use.

This position is located in Wilmington, DE and may require to travel up to 15%, both domestic and international.

Qualified applicants will be considered without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability or any other protected class.

Job Type: Full-time

Pay: $140,000.00 - $165,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Work Location: In person