- Job Title
- Process Engineer
- Germantown, WI 53022
- Other Location
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 Sterling’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.
Diversity and Inclusion
Sterling values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.
Why consider Sterling?
Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.
We are a fast growing, dynamic business with facilities in the UK and the US, where we employ more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.
Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.