The Process Automation Engineer Specialist provides automation system support and technical expertise to enable the reliable and compliant supply of quality vaccine products, involving problem resolution, process control implementation, and troubleshooting.
Compensation
The salary range for the primary location of this role is: $87,300.00 - $137,400.00
Responsibilities
Problem resolution, implementation of process control and data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental requirements.
Work closely with Manufacturing, Quality, and Engineering organizations to support automated systems within GMP operations.
Comply with global policies, procedures, guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP).
Serve as the technical owner for automation system components supporting manufacturing processes, including direct shop-floor support.
Design, implement, test, and close change controls associated with automation-related corrective actions and continuous improvement initiatives.
Support the production of life-changing therapies in a state‑of‑the‑art viral vector facility, executing complex virus purification and filtration processes while ensuring GMP compliance.
Compensation
The compensation range for this role is $22.49 - $28.11 hourly annually depending on experience and qualifications.
Responsibilities
Prioritize manufacturing schedule requirements and execute daily manufacturing schedule
Troubleshoot equipment and processes in partnership with Manufacturing Science and Technology
Conduct analytical tests such as osmolality, pH, conductivity and filter integrity testing
Communicate problems and observations with management
Support manufacturing operations for clinical and commercial cell therapy programs through the execution of cGMP‑compliant production activities.
Compensation
The anticipated hourly rate for this position in NJ is $40.86 – $45.67 plus bonus. The final hourly rate offered to a successful candidate may vary and will depend on factors such as experience, skillset, education, and business needs.
Responsibilities
Support manufacturing operations for clinical and commercial cell therapy programs
Coordinate daily production scheduling and resource planning in partnership with Manufacturing leadership
Execute and oversee key manufacturing processes, including cell culture, aseptic processing, cell expansion, separation, counting, and cryopreservation
Assist with the development, review, and maintenance of manufacturing documentation, including SOPs, work instructions, forms, and protocols
Train and mentor Manufacturing Associates in technical operations, aseptic techniques, and cGMP requirements
Requirements
High School Diploma
Associate degree in a scientific, engineering, or biotechnology discipline
Bachelor’s degree in a scientific or engineering discipline
Lead the manufacture of clinical supply of investigational biopharmaceutical molecules, manage GMP upstream processing, and drive process improvement.
Compensation
We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programs, pension plan membership, and shares and savings programme.
Responsibilities
Leads the manufacture of clinical supply of investigational biopharmaceutical molecules
Leads or works on projects and assignments where independent action and a high degree of initiative and knowledge are required
Supports the technology transfer process through active participation in ensuring that new processes fit and execute consistently
Troubleshoots problems in the execution of processing activities; proactively assesses options and impact and takes action to rectify or communicate to appropriate decision makers
Identifies process improvement opportunities with impact on safety, compliance, and efficiency/cost
Senior Engineer responsible for defining operational and technical standards for PCI sites producing medical devices, driving process improvements, technology transfer, and GMP support.
Responsibilities
Actively participate in PCI Safety Program
Provide technical mentorship to junior MSAT Engineers
Support experimentation and manufacturing work
Contribute to evaluation of novel platform technologies
Lead technology transfer across biopharmaceutical/medical device lifecycle
Requirements
BS degree in an Engineering discipline with preference for Chemical or Life Sciences
Senior Engineer responsible for defining operational and technical standards for PCI GMP manufacturing sites, driving process improvements, technology transfer, and equipment support.
Responsibilities
Actively participate and provide input for PCI Safety Program
Provide technical mentorship to junior MSAT Engineers
Support experimentation and manufacturing work including development and pilot scale studies
Contribute to evaluation of novel generic platform technologies
Act as technical expert on equipment, systems, and processes
Requirements
BS degree in an Engineering discipline with preference for Chemical or Life Sciences
Responsible for the development, optimization, scale-up, and routine execution of manufacturing operations for pharmaceutical products, with a focus on on-site supervision at CMOs.
Compensation
$124,000.00-161,000.00 Annual
Responsibilities
CMO Oversight: Real-time and on-site supervision of CMO execution of routine manufacturing as well as technology transfer, optimization, new equipment install, and process validation activities
Design, develop, and optimize manufacturing processes for pharmaceutical APIs and formulations; with an emphasis on particle engineering via spray drying and low fill weight powder encapsulation
Contribute to the transition of spray drying and other drug product processes from pilot and commercial scale at primary and secondary CMOs
Troubleshoot spray drying and other drug product process equipment, ensuring efficiency and compliance with GMP regulations
Develop and execute validation protocols (IQ, OQ, PQ) for spray drying and other drug product processes
The Project Management Group Leader is responsible for managing and delivering complex customer programs for oral solid dosage pharmaceutical products, as well as leading the Italy PM team.
Compensation
Gross Annual Salary range (RAL): €65k to €85k
Responsibilities
Directly supervise, coach and develop a small team of PMs
Establish objectives and individual development plans
Hold regular one-to-ones and provide timely feedback