"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-New Product Introductions is responsible for the evaluation of new API manufacturing processes and intermediates. Provides technical support and oversight for processes that are awarded to the Wilmington site 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.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
- Technical evaluation of incoming proposal requests from potential customers for exclusives products
- Development of site plant fit, mass balances, detailed process hazards evaluation
- Cross functional collaboration to determine capital requirements, capacity availability, and overall site ability to manufacture API and intermediates under evaluation
- Provides day-to-day support of assigned processes or assets, creates and maintains documentation such as batch production records, operation procedures, criticality analysis, and key and controlled parameter documents; assigned processes may be with contract manufacturing sites.
- Lead investigation efforts on assigned products in Wilmington or participate in CMO investigations 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.
- Represent operations in engineering projects and coordinate small engineering projects.
- Prepare reports (campaign, monthly, or ad hoc) to keep management informed of work in progress with expected completion dates.
- Conduct or participate in development projects including laboratory, pilot plant or plant scale investigations to provide improved procedures, equipment or processes for existing products.
- Manage and execute the process and cleaning validation of new and transferred products.
- Support the introduction of new processes to the Wilmington site by coordinating and executing the preparation activities for process start-ups and supply technical coverage.
- Assist in new and existing process and equipment design.
- Execute 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.
- Conduct training for operations and maintenance personnel.
- 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 or System (equipment) Owner.
- Must be able to produce high quality and accurate work in a timely manner to meet the production schedule.
- Manage and coordinate multiple project priorities and work effectively across the organization in completing projects on time and in budget.
- Cross-site collaboration within the Siegfried Network to present and deliver the most cost effective and efficient solution to exclusives customers
- Involvement with PLC’s, DCS/BPCS will vary by plant – these systems are tools used by the Process Engineer to accomplish the job deliverables.
- Participate in plant safety programs such as PHA’s of new and existing processes to maintain and/or improve operations safety.
- Serve on various committees and teams to enhance operations at the Wilmington site as requested by supervision.
- Assist 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.
- Carry out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Comply with all company and site policies and procedures and the intent of our Credo.
- Assume responsibility for the safety, environmental, quality, and business effects of work performed.
- Successfully complete regulatory and job training requirements.
- Maintaining proper housekeeping at all times.
- Be available for overtime work on a scheduled or emergency basis. Occasional travel may be necessary.
- Other projects or assignments as requested by management.
QUALIFICATIONS
EDUCATION and/or EXPERIENCE
B.S. in Chemical Engineering, Mechanical Engineering, or equivalent; 4 to 6 years of experience at least two years of chemical manufacturing experience.
LANGUAGE SKILLS
- Read, analyze, and interpret 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 present information to site management, public groups, and/or boards of directors.
MATHEMATICAL SKILLS
- Apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
- Apply 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
- Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Define 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.
- Manage and coordinate multiple project priorities.
- Computer knowledge, primarily Microsoft Word and Excel, Minitab 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.
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: $110,000.00 - $145,000.00 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
