Process Engineer/Senior Process Engineer

"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 Process Engineer is responsible for the API manufacturing processes and intermediates. Provides technical support for processes including performing analysis to measure process performance and implementing improvements in process cycle time, yield, and quality to maximize operations efficiency. Support introduction and validation of new and existing products. Provides expertise to new equipment design, installation and qualification. Plans and conducts activities related to the development of new processes including researching current and emerging technologies, evaluating process cost, quality and capability alternatives, and performing process characterization and optimization using designed experiments, and problem solving and decision-making tools.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

· Designs comprehensive engineering activities to develop and implement effective, high-quality processes and design guidelines.

· Provides complex design reviews and feedback for improvements in manufacturability.

· Develops equipment, materials and process performance requirements, performs vendor searches and equipment evaluation to ensure adequate capability to produce quality products in required quantities at effective costs.

· Designs experiments and capability studies, develops process specifications, and designs and procures process tooling.

· Analyzes new processes and equipment with the intent of achieving continuous improvement of present methods.

· Communicates and monitors process and material quality targets.

· Measures performance to targets and implements remedial actions as instructed.

· Develops process documentation and training materials for new processes, materials and equipment.

· Provides day-to-day support of assigned processes creates and maintains documentation such as batch production records, operation procedures, criticality analysis, and key and controlled parameter documents.

· Lead investigation efforts by analysis and correction of both process and equipment problems to maintain or improve existing site operations.

· Responsible for process surveillance programs on issues such as process control, yields, cycle times, quality, and change over. Prepare written interpretations of plant operating data and implements corrective action.

· Represents operations in engineering projects and coordinate small engineering projects.

· Prepares reports (campaign, monthly, or ad hoc) to keep management informed of work in progress with expected completion dates.

· Conducts or participates in development projects including laboratory, pilot plant or plant scale investigations to provide improved procedures, equipment or processes for existing products.

· Manages and executes the process and cleaning validation of new and existing products.

· Supports and provides guidance for the introduction of new processes by coordinating and executing the preparation activities for process start-ups and supply technical coverage.

· Assists in new and existing process and equipment design.

· Executes cost reduction and productivity improvement projects using Process or Design Excellence techniques. Utilizes appropriate risk management tools such as FMEA, HAZOP, and business risk evaluations.

· Conducts training for operations and maintenance personnel.

· Maintains knowledge of cGMPs, process safety practices and environmental standards.

· Serves on committees and teams, including PHA, PSSR, and investigative teams and site group initiatives.

· Provides input on financial variances for assigned processes or assets.

ADDITIONAL POSITION REQUIREMENTS

· Serves in the role of a Synthesis Expert/Owner or System (equipment) Owner.

· Mentors, and assists in the development of peers and Process Engineers.

· Must be able to produce high quality and accurate work in a timely manner to meet the production schedule.

· Manages and coordinates multiple project priorities and works effectively across the organization in completing projects on time and in budget.

· Involvement with PLC’s, DCS/BPCS will vary by plant – these systems are tools used by the Process Engineer to accomplish the job deliverables.

· Participates in plant safety programs such as PHA’s of new and existing processes to maintain and/or improve operations safety.

· Serves on various committees and teams to enhance operations as requested by supervision.

· Assists in the preparation for, and detailing with various regulatory agency audits (i.e., FDA inspections, Corporate QA audits, in-house QA audits). Assists in keeping regulatory documentation current.

· 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 and the intent of our Credo.

· Assumes responsibility for the safety, environmental, quality, and business effects of personal work and of work performed as a team.

· Successfully completes regulatory and job training requirements.

· Maintains proper housekeeping at all times.

· Be available for overtime work on a scheduled or emergency basis. Travel may be necessary.

· Other projects or assignments as requested by management.

SUPERVISORY RESPONSIBILITIES

· Mentor entry level Process Engineers

· May serve as a production supervisor as required.

· May supervise coops, interns.

EDUCATION and/or EXPERIENCE

B.S. in Chemical Engineering, Mechanical Engineering, or equivalent; at least four years (at least 2 years with MS) of chemical manufacturing experience.

LANGUAGE SKILLS

· Reads, analyzes, and interprets complex scientific and technical journals, financial reports, and legal documents.

· Ability to respond to sensitive inquiries or complaints from customers, regulatory agencies, or members of the business community.

· Effectively presents information to site management, public groups, and/or boards of directors.

MATHEMATICAL SKILLS

· Applies advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.

· Applies mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

REASONING ABILITY

· Interprets a variety of instructions furnished in written, oral, diagram, or schedule form.

· Defines problems, collect data or information, establish facts and draw valid conclusions.

OTHER SKILLS ABILITIES OR QUALIFICATIONS

· Must be able to work effectively with others and with minimal supervision.

· Manages and coordinates multiple project priorities.

· Computer knowledge, primarily Microsoft Word and Excel, Minitab, SAP, and Visio.

PHYSICAL DEMANDS

· While performing the duties of this job, the employee is regularly required to sit, use hands to finger or feel and reach with hands and arms.

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

· Must be capable of moving around the plant to perform on-site investigations.

We consider candidates 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: $90,000.00 - $130,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person