Job Title: Sr. Process Engineer, Third Party Management
Location: Columbus, OH
Job Type: Full time
Req ID: 12238
Description
We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated
Sr. Process Engineer, Third Party Management to join our team.
Responsibilities
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:
- Support technical evaluation of 3rd party/ CMO capabilities, process development, registration lots manufacturing, and FDA filings.
- Perform evaluation, scale-up, process validation, site transfer (in/out), and lifecycle maintenance.
- Coordinate quality investigations, process change management, and project communications during development/ transfer/ launch/ life-cycle projects.
- Lead the transfer of selected in-house products (on-site development/ manufacturing/ testing) for cross learning and alignment with Hikma’s internal practices.
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.).
- Co-lead process development, registration, and FDA filing tasks with R&D and project teams from 3rdparty/ CMO and Hikma and establish robust control strategy for future commercial process.
- Collaborate with development partners (e.g. Product Development) during development, pilot lot production, registration, etc. to develop product formulation, and process flow, and resolve complex issues relating to CPPs, CQAs, AQL, analytical methods/ testing, quality deviations and other process risks.
- Collaborate with Analytical Development, Quality labs etc. to set-up testing requirements for in-process controls, release and stability; influence in establishing product specifications based on process and data trends.
- Lead planning and execution of complex experimental/ developmental studies to mitigate future process risks by evaluating financial and quality impact for Hikma.
- Create and/ or review documentation (e.g. SAP Master Data, development/ registration protocols, reports, batch records etc.) based on process design parameters (e.g. formulation and processing steps) mutually agreed upon with product development partners and quality procedures.
- Travel to 3rd Party/ CMO locations during development/ registration manufacturing to co-lead with development partners, implement process design, and mitigate risk-factors for scale-up/ process validation.
- Drive effective Risk Assessment processes at applicable development gates, in collaboration with development partners; identify critical risk areas and develop remediation plans to address them.
- Co-lead with Product Development to generate development/ registration QbD reports and ensure robust documentation of development history/data prior to process validation.
- Consult on FDA filing/ correspondence strategy and documentation requirements for process related sections of the ANDA/ NDA submission.
- Collaborate with Drug Regulatory Affairs (DRA) at 3rd Party/ CMO and Hikma to author/ or review documentation required for product filing (ANDAs, NDAs, PAS, CRLs, and other FDA correspondences) to support timely approvals.
- Lead the planning and execution of scale-up/ evaluation, process validation/ PPQ and commercial production/ CPV of new and existing products (3rd Party/ CMO, Transfer (In/ Out) Buy-ins, Inter-site etc.) following Hikma requirements; drive resolutions to complex process problems and influence teams to adopt solutions to meet commercialization timelines/ deliverables.
- Lead as a process champion/ point of contact for process validation/ commercial production at Hikma for 3rd Party/CMO team.
- Lead proactive planning and strategies for the scale-up/ transfer/ validation lot manufacturing including commercial lot size determination, no. of lots for validation, documentation etc. to support product launch goals; resolve differences in approach between 3rd Party/CMO and Hikma.
- Drive effective Risk Assessment processes including statistical data analysis at applicable development gates, in collaboration with development partners and Operations partners; identify critical risk areas and develop remediation plans to address them.
- Create and/ or review documentation (e.g. Master Manufacturing Formula/ batch records, protocols/ reports, technical justifications for matrix approach etc.) for scale-up, evaluation, and validation batch production, based on development process design parameters, scale-up considerations, and best practices, as mutually agreed by 3rd Party/ CMO and Hikma Quality.
- Travel to 3rd party locations as lead representative of Process Transfer - Technical Services during evaluation/ scale-up/ process transfer/ validation/ commercial lot manufacturing to provide subject matter expertise and around-the-clock technical support on process and quality requirements of Hikma.
- Lead functional and cross-functional investigations in collaboration with Quality function of 3rd Party and Hikma to determine root causes, assess product impact, determine path forward, and develop/ implement CAPAs. Influence organizational partners to support these initiatives.
- Lead process improvement/ optimization, CAPA, and other process changes during commercial manufacturing/ CPV stage. Influence organizational partners to support execution of these initiatives.
- Coordinate with 3 PM Quality/ Change Management, Drug Regulatory Affairs (DRA) etc. to lead the implementation of critical process changes (e.g. API/ raw materials, process parameters, batch size optimization etc.).
- Lead the development of response strategy and corrective actions to resolve process quality/ product stability deviations on commercially marketed products in coordination with Quality, DRA, etc.
- Lead selected in-house projects (on-site development/ manufacturing/ testing) at registration, launch, and lifecycle transfer phase to stay aligned with Hikma’s current internal practices/ SOPs and contribute in the success of Hikma’s organic business portfolio.
- Represent Technical Services as process lead during registration, evaluation, transfer, launch, and commercial operations and execute similar duties highlighted in above point #2, and #3 for selected in-house products that are developed, manufactured and tested on-site at Hikma.
- Perform peer review of documentation (protocol, reports, batch records etc.) and raw data (e.g. LIMS reports) from fellow Technical Service colleagues to ensure accuracy and alignment with general conventions.
- Drive and implement complex process improvements/ changes (e.g. new equipment/ process technology) and revalidation of commercial products to meet compliance requirements, minimize quality deviations and/ or improve cost advantage.
- Lead the process transfer of launched/ commercial products (in-house products only) from Technical Services to Life-Cycle Operations by ensuring effective knowledge transfer and documentation.
- Support Life-Cycle Operations to plan and perform continuous process verification (CPV) or re-validation.
- Mentor and develop other members of the Technical Services department and promote knowledge transfer within Technical Services. Act as a subject matter expert on core technologies and/or process engineering/ validation topics.
- Identify and proactively create opportunities to mentor Process Engineer(s) on equipment/ process technologies, validation strategies, quality investigations/ CAPA, conflict management etc.
- Lead knowledge sharing of best practices, quality and safety incidents, new process technologies, etc. within Technical Services organization.
- Drive documentation to standardize best practices, and author Work Instructions, SOPs, etc. to support process documentation requirements under Hikma’s quality management system.
- Support Technical Services management to resolve complex challenges related to process/ equipment, validation, quality investigations etc.
Qualifications
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
- 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 effective corrective actions across individual and cross-functional teams.
- Demonstrated situational leadership with the ability to work independently, make strategic decisions, and execute highly complex technical and operational initiatives with minimal supervision.
- Strong teamwork and leadership skills, including influencing, leading, and facilitating teams on highly complex projects and initiatives.
- Demonstrated mentoring and training experience, providing technical guidance both within and outside the department, including support for junior engineers, production coaches, and technicians.
- Ability to travel domestically and internationally for multiple days to support external partnerships, project activities, and business objectives.
Equal Opportunity Employer
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
