Process Engineer - Sterling Pharma Solutions
Sterling Pharma Solutions

Summary of Role
The Process Engineer is accountable for driving results in a fast-paced environment by supporting 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 execution of the Sterling Values and non-negotiables, as well as expertise in functional competencies included in this position profile.

Your Responsibilities

• Processes Fit assessment, Mass Balance, Energy Balance and Equipment Suitability assessments.
• Partners with Research and Development to ensure process manufacturability during design.
• 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, assists in investigating and documenting process deviations and CAPAs.
• Provides plant support.
• Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA.
• Ability to draw and interpret graphs and charts.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.

Requirements for the Role

• Requires a bachelor's degree in Engineering; Chemical Engineering strongly preferred.
• Previous work experience in a regulated environment a plus.

What We Offer
We offer a competitive compensation and benefits package including medical/dental/vision/life insurance, paid time off, bonus program, 401k match, tuition reimbursement, 24/7 employee assistance program, flexible work hours, and the opportunity for career training and development.

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.

What We Offer
We offer a competitive compensation and benefits package including medical/dental/vision/life insurance, paid time off, bonus program, 401k match, tuition reimbursement, 24/7 employee assistance program, flexible work hours, and the opportunity for career training and development.

Location
This position is located in Germantown, WI, a vibrant city northwest of Milwaukee in Southeast Wisconsin. A great place to live, work and raise a family, Southeast Wisconsin offers a variety of activities and diverse cultural scene.

Why Consider Sterling?
Sterling Pharma Solutions is a global contract development and manufacturing organization (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, Europe and the US, where we employ more than 1300 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.

Sterling Pharma Solutions is an equal opportunity employer.
Be caring. Be transparent. Be willing. Be reliable.

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