Senior Specialist, Engineering- Biologics External Manufacturing Technical Operations

Our Large Molecule Technical Operations Unit is seeking a highly motivated individual to fill an open position to support drug substance tech transfer and commercial manufacture within our External Manufacturing Network. This is an exciting opportunity to work with key strategic external partners, grow technical experience in biologics or vaccines manufacturing, and work on high visibility network initiatives. Our team strives to provide technical excellence in our work and be strong partners, collaborators, and leaders within the large molecule line of business at our company.

Our Engineers help ensure that internal and external manufacturing operations remain operational, continuously improve, and innovate.

With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.

• Work with external partners to achieve business goals and to establish a common culture that benefits both our company, external partners, and patients.
• Lead and act as the primary interface on technical issues between technical operations and external partner drug substance manufacturers.
• Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
• Responsible for technical activities for the commercial manufacturing process at the external partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.
• Develops solutions to complex technical issues that require a high degree of ingenuity, creativity and innovation.
• Requires understanding and application of principles, concepts, practices, and standards that govern the manufacturing of sterile products.
• Provide on-site coverage at external partner in support of commercial and / or tech transfer person in plant activities.
• Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with operations, quality, and external partners.
• Ensure that external partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with operations, quality, and regulatory.
• Responsible for participation in creating, sharing, and adopting best practices and business process strategies.

Minimum Requirement:
Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.

• Minimum of 8 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology or Engineering.
• Ability to work independently as well as excellent organizational skills.
• Strong professional and interpersonal communication skills.
• Must be able to multi-task and work within tight deadlines.
• Strong analytical problem-solving skills, root cause analysis, and risk assessment/mitigation.
• Proven team building skills.
• Travel will be a requirement of this position at approximately 25%.

• Experience in biologics or large molecule manufacturing.
• Project management experience.
• Experience in deviation management and/or change control and/or equipment support, and/or project management.
• Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections.

• Biologics, Deviation Management, DP Operations, Facility Design, GMP Compliance, Manufacturing, Manufacturing Operations, Manufacturing Process Validation, Project Management, Regulatory Compliance, Sterile Manufacturing, Technical Transfer, Working Independently, Writing Technical Documents

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit…