Job Title: Process Engineer (Chemical)
Location: Germantown, WI 53022
Work Type: Full-Time, Direct-Hire, On-Site (M-F 1st Shift)
Summary of Role:
The Process Engineer supports tech transfers and scale-ups of API processes from Research and Development into cGMP manufacturing. The Process Engineer is responsible for assessing process fit for new projects, troubleshooting unexpected manufacturing events, preparing, conducting and evaluating process validation activities, and providing on-going support of commercial manufacturing. The Process Engineer works closely with Research and Development, Manufacturing, QA, Regulatory, EHS, and Engineering to ensure first time right process scale-ups, tech transfer, and robust production of cGMP API materials. The position requires superior leadership behaviors of the company's core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.
- Processes Fit assessment, Mass Balance, Energy Balance and Equipment Suitability assessments.
- Partners with Research and Development to ensure process manufacturability during design.
- Seeks opportunities to improve process performance within process ranges defined by large-scale equipment capabilities.
- Assists in Designing Experiments needed to establish Proven Acceptable Ranges for critical and key process parameters.
- Understands relationships between Process Yield and Product Quality to achieve Process Optimization.
- Writes protocols and reports needed to support Process Validation, process changes and equipment modifications.
- Supports the creation and maintenance of cGMP production records.
- Provides training to manufacturing staff on manufacturing procedures.
- Troubleshoots unexpected events during cGMP manufacturing, assist in investigating and documenting process deviations and CAPAs. Evaluates product impact of process excursions outside Proven Acceptable Ranges.
- Provides plant support.
- Participates as Process Engineering representative on cross-functional or cross-site teams in support of major process/system improvements and capital projects.
- Acts as a Subject Matter Expert in relation to applicable engineering procedures, and process/cleaning validation.
- 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.
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
- An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.
Education and Experience:
- Requires a Bachelor's Degree in Engineering; Chemical Engineering strongly preferred.
- Minimum 4 years of experience in pharmaceutical manufacturing environment or equivalent regulated industry.
- Previous work experience in a regulated environment a plus.
- Maintains a safe, clean and organized work environment free of safety hazards.
- Ability to work with people at all levels of the organization.
- Ability to perform complex math functions, compute ratios, rates and percentages.
- Strong analytical skills; collect data, evaluate its relevancy, conduct comparative evaluations and present it in a professional manner including graphs and charts.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
- Ability to read, analyze and interpret general business periodicals, professional journals technical procedures and governmental regulations.
- Ability to write reports, business correspondence and procedure manuals.
- Ability to effectively present information and respond to questions from groups of managers and clients.
- Working knowledge of cGMP in a pharmaceutical or regulated environment required.
- Basic knowledge of computers and Microsoft Office software products.
- Applies job skills, company policies and SOPs to complete a variety of tasks.
- Receives general instructions on routine work, detailed instructions on new projects or assignments.
- Candidates need to be competent with IT systems, and Microsoft Office including Outlook, PowerPoint, Word and Excel.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
Duties, responsibilities and activities may change at any time with or without notice.
For immediate consideration apply today!
You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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