Senior Process Engineer – Technical Services

Jobtailor; Columbus (OH); On-site; USD 110,000 - 180,000; Full time

Job summary

Hikma in the United States seeks a seasoned Process Transfer and Validation Leader to drive cGMP compliance, registration filings (ANDA/NDA/PAS), and scale-up for both 3rd party/CMO and in-house products. The role requires leading cross-functional teams across R&D, Regulatory, Quality, and Production to ensure robust processes and successful product launches.

You will conduct risk assessments, develop robust control strategies, and guide documentation for filings and validation batches.

Qualifications

• > Bachelor's degree holders with 6+ years pharma experience or a Master with 4+ years; or 7+ years in related field; or PhD with 2+ years.
• + Experience in technology transfer, process development/validation, formulation, manufacturing, or quality within pharmaceuticals.
• + Strong knowledge of FDA, cGMP, and regulatory requirements (DEA, OSHA, etc.).
• + Expertise in formulation development, process scale-up, validation/PPQ, and equipment.
• + Ability to travel domestically and internationally as needed.

Responsibilities

• Consult as Process and Formulation Champion on cGMP/FDA quality requirements and execute process registration (ANDA, NDA, PAS) and scale-up/validation for 3rd party/CMO and in-house products.
• Lead Hikma’s Technical Services representative activities for in-house processes and site visits.
• Drive risk assessments and data analysis for process scale-up and design improvements (PAT, DOE).
• Lead strategy development for filing and validation, including lot sizes, sampling plans, and documentation for registration/transfer.
• Collaborate with Regulatory Affairs to author/review FDA filing documentation (ANDAs, NDAs, PAS).
• Coordinate with Quality/Change Management and DRA to implement critical process changes and CAPA.

Skills

Cross-functional leadership

DOE

Process scale-up

CAPA implementation

Data analysis

Regulatory knowledge

Education

Bachelor's degree in Engineering/ Chemistry/ Pharmacy

Master's degree in a related field

Ph.D. in a related field

Job description

• Consult as Process and Formulation Champion on cGMP/ FDA/ Hikma quality requirements and execute process registration (ANDA, NDA, PAS, etc.)/ scale-up/ validation and commercial production for 3rd Party/ CMO & in-house products during project selection, process development, filing, transfer, evaluation, launch and life-cycle phase
• Lead as Hikma’s Technical Services representative for in-house process flow & equipment requirements for different products (solids, non-solids, nasals, inhalation, etc.) and spearhead 3rd Party/ CMO site visits, process and equipment requirements, and other technical considerations during project selection, and execution
• Drive gap and risk assessments including statistical data analysis 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 for filing and validation (e.g. lot sizes, number of lots, sampling plan etc.) and drive requirements (e.g. protocols, batch records, etc.) for registration scale-up, evaluation, transfer, and process validation batch production
• Create and/or review documentation (e.g. Master Manufacturing Formula/ batch records, protocols/ reports, technical justifications for matrix approach etc.), and master data for production of batches for registration/ filing/ scale-up, evaluation, and process validation
• Travel to 3rd party locations as lead representative of Process Transfer - Technical Services during registration/ evaluation/ scale-up/ process transfer/ validation/ commercial lot manufacturing to provide subject matter expertise and technical support on process and quality requirements of Hikma to mitigate risks during commercial production
• Lead process development, registration, and FDA filing tasks with R&D and project teams from 3rdparty/ CMO and Hikma to establish robust control strategy for future commercial process
• Collaborate with stakeholders (e.g. Product Development, Production etc.) during development, pilot lot production, registration, etc. to optimize or 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
• Co-lead with Product Development to generate development/ registration QbD reports and ensure robust documentation of development history/data prior to process validation/ PPQ
• 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
• Leverage lessons from registration scale batches and coordinate with Production/ Engineering team to drive procurement or modification of key manufacturing equipment to support commercial production
• Lead the planning and execution of process transfers and 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/ product launch timelines/ deliverables
• Lead as a process champion/ point of contact for process validation (process design, PPQ, & CPV) / commercial production at Hikma
• 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
• 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 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 strategies and corrective actions to resolve process quality/ product stability deviations on commercially marketed products in coordination with Quality, DRA, etc.
• 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.

Requirements

• Bachelor’s degree (Engineering, Chemistry, Pharmacy, or related field) with 6+ years of relevant pharmaceutical experience; or 9+ years in a related technical field OR Master’s degree with 4+ years of relevant experience; or 7+ years in a related technical field OR Ph.D. with 2+ years of relevant experience; or 3+ years in a related technical field
• Experience in technology transfer, process development/validation, formulation, manufacturing, or quality within pharmaceuticals
• Strong knowledge of FDA, cGMP, and regulatory requirements (DEA, OSHA, etc.)
• Expertise in formulation development, process scale-up, validation/PPQ, and equipment
• Experience with multiple dosage forms (e.g., tablets, capsules, inhalation, semi-solids, transdermals)
• Proven ability in process design, experimental methodology (DOE), and data analysis
• Skilled in problem-solving, root cause analysis, and CAPA implementation
• Ability to lead cross-functional teams and influence internal/external stakeholders
• Strong documentation, communication, and conflict management skills
• Ability to travel domestically and internationally as needed