Process Engineer

As the Process Engineer, you will support 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.

Your responsibilities

• 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.
• Embodies our company values, which are : be reliable, be caring, be transparent and be willing.

Requirements for the role

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. Please note that compensation is based on a variety of factors when extending offer, including but not limited to, the role, responsibilities, candidate experience, education, qualifications, and business considerations.

Candidates must be eligible to work in the United States without requiring company sponsorship to obtain or keep U.S. work authorization.

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.