Sr. Process Engineer,Third Party Management Job Columbus area,Ohio USA,Pharmaceutical

Sr. Process Engineer, Third Party Management

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. In this role, you will be responsible for leading the transfer of 3rd party/ CMO products (externally contracted for development/ manufacturing/ testing, Buy-ins, Site Transfers (in/ out), life-cycle) from R&D to Commercial Operations as a Process Champion from Hikma.

Key Responsibilities:

Consult as Process Champion on cGMP/ FDA/ Hikma quality requirements and lead the planning and execution of process scale-up/ validation and commercial production for 3rd Party/ CMO products during project selection, process development, filing, transfer, evaluation, launch and life-cycle phase.

Lead as Hikma's Technical Services representative during 3rd Party/ CMO site visits, and project selection, and execution.

Consult on Hikma's commercial operations requirements for process/ equipment, analytical/ physical testing, validation, documentation, training, cGMP and QbD controls etc.

Drive gap assessment for process scale-up, and process design/ improvement initiatives (e.g. PAT, DOE) during development/ registration/ transfer and lead mitigation and implementation activities.

Lead strategy development (e.g. lot sizes, number of lots, etc.) and drive requirements (e.g. protocols, batch records, etc.) for scale-up, evaluation, transfer, and validation batch production.

Execute project deliverables by employing prior knowledge/ experience and/ or by continuously learning of unique dosage forms and process technologies (e.g. soft gels, transdermal patches, etc.).

Qualifications:

B.S. degree in Engineering, Chemistry, Pharmacy, or related scientific discipline plus a minimum of six (6) years of experience in pharmaceutical technology transfer, project management, quality assurance, product development, manufacturing, or applicable pharmaceutical experience, or nine (9) years of experience in another technical field in product formulation development, process development, technology transfer and validation, and/or process engineering.
Alternatively, a M.S. degree in Engineering, Chemistry, Pharmacy, or related scientific discipline plus a minimum of four (4) years of experience in pharmaceutical technology transfer, project management, quality assurance, product development, manufacturing, or applicable pharmaceutical experience, or seven (7) years of experience in another technical field in product formulation development, process development, technology transfer and validation, and/or process engineering.
Alternatively, a Ph.D. degree in Engineering, Chemistry, Pharmacy, or related scientific discipline plus a minimum of two (2) year experience in pharmaceutical technology transfer, project management, quality assurance, product development, manufacturing, or applicable pharmaceutical experience, or three (3) years of experience in another technical field in product formulation development, process development, technology transfer and validation, and/or process engineering.
Expert knowledge of pharmaceutical development and manufacturing regulations, including FDA, cGMP, DEA, OSHA, and other applicable regulatory and company requirements.
Expert understanding of pharmaceutical formulation development, processing equipment, Quality by Design (QbD), and cGMP manufacturing, with emphasis on process scale-up, optimization, and validation.
Proven ability to develop, scale up, and validate pharmaceutical processes for complex dosage forms (e.g., soft gels, transdermal systems, foams) and quickly adapt to new process technologies outside prior experience.
Strong attention to detail with a focus on accurate, high-quality documentation.
Demonstrated conflict management skills, including collaborating with cross-functional teams and external partners, both domestic and international, to achieve mutually beneficial solutions.
Proven ability to design complex experiments supporting pharmaceutical development, process transfer, and validation activities.
Expert problem-solving and investigation skills, including identifying root causes, resolving complex issues, and driving…