Title:  Process Engineer/Transfer - Technical Services, 1st Shift (M-F, 7a-430p) - 7321

Job Title: Process Engineer, Process Transfer – Technical Services

Location: Columbus, OH

Job Type: Full time

Req ID: 7321

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 750 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.  Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

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 Process Engineer, Process Transfer – Technical Services to join our team.  In this role, you will be responsible for transferring products of varying types (Generic commercialization, Site Transfers, Buy-ins, Third Party & key lifecycle (Alt. API) from R&D or applicable partner to Operations, including supporting process development and registration, performing scale-up / validation, site transfer, start-up of commercial production, and transfer to lifecycle support.  Minimize obstacles during development, product transfer, validation, and commercialization through utilization of risk-mitigation strategies, best practice sharing, and influence with R&D, Supply Chain, and Operations colleagues.  

Key Responsibilities:

• Collaborates with development partners/customers during the process development and registration of new product NDAs, ANDAs, and / or site transfers, ensuring that all project timelines are met.   

• Represent Process Transfer Technical Services and Operations in the development and filing of new products.

• Collaborate with development partners (e.g. Product Development) during development and pilot scale batch production.

• Provide critical review of new products/processes regarding fit with operational capabilities (e.g. batch sizes vs. equipment capacity, and technical challenges of the product/process such as poor flow, segregation, or batch splitting, etc.), independently for processes of low to medium complexity (e.g. low complexity may be direct blend or bin-mill-bin processes; medium complexity may be roller compaction or fluid bed granulation processes without any particular difficulties), and in consultation with functional management and /or Senior Process Engineers for complex processes (e.g. roller compaction or fluid bed granulation process with difficult formulations [due to API sensitivities, poor flow properties, etc.], or processes with approaches rarely used at Hikma, such as top spray granulation or inclusion of API in the granulating solution). 

• Provide feedback to product development or partners on potential critical mismatches between new products/processes and operational capabilities, identify potential non-critical process optimization opportunities.

• Collaborate with product development or partners in the selection and/or design of processes and systems which meet product and regulatory requirements, and are compatible with our manufacturing practices, while meeting marketing and financial needs.  May require assistance from functional management or Senior Process Engineers to influence development partners in the selection of processes and/or systems.

• Create documentation (e.g. SAP Master Data, PMX production procedures, registration batch lot records) based on process design parameters (e.g. formulation and processing steps) mutually agreed upon with product development partners.

• Collaborate with product development or partners to drive shared business ownership and continuous process improvements, particularly in regards to process performance (Zero Defects, RFT, Throughput Time, Physical Yield, etc.).

• Execute assigned project deliverables with moderate guidance from functional management and/or Senior Process Engineers; may require guidance on technical aspects of processes of medium to high complexity, as well as problem solving approaches for dealing with project roadblocks (technical and/or logistic).

• Coordinate Process Risk Analysis, Scale-up/Transfer trials, and Process Validation of new products (Alternate API, Buy-ins, Generic, 3rd Party, Inter-site) as the Technical Services team representative with support from functional management and/or Senior Process Engineers to ensure that new products meet requirements for quality, cost and manufacturability. 

• Perform Risk Assessment processes at applicable development gates, in collaboration with development partners and Operations partners; collaboratively identify critical risk areas and develop potential remediation plans for team review & selection.

• Collaborate with development partners and Operations partners to mitigate risks as identified in Risk Assessment.

• Create documentation (e.g. SAP Master Data, PMX production procedures, Master Manufacturing Formula) for scale-up, evaluation, and validation batch production, based on development process design parameters (e.g. formulation and processing steps), scale-up considerations, and best practices, as mutually agreed upon with development partners.

• Develop validation strategies and documentation (e.g. protocols) based on standard approaches modified as necessary based on critical process reviews, independently for processes of low to medium complexity, and in consultation with development partners, functional management, and/or Senior Process Engineers for complex processes.

• Collaborate with product development and partners during scale-up and validation production to ensure all applicable launch deliverables are met and to drive post-launch optimization opportunities.

• Liaise with lifecycle team to ensure consultation regarding launch projects, to enable efficient transfer of products to lifecycle support.

• Collaborate with peers (e.g. Physical Flow, Process Optimizers, Equipment Optimizer, Quality Optimizer, and QAI) to identify and prioritize product quality and process robustness optimization opportunities.

• Pursue these process optimization opportunities to maximize value of new products at launch.

• Provide around-the-clock technical support to production, including assessment of non-standard events, implementation of path forward (e.g. Request for Technical Service), and determination of product impact; provide recommendations for scenarios of low to medium complexity and business impact, and with moderate support from development partners, functional management, and/or Senior Process Engineers for complex scenarios.

• Participate in and lead functional investigations and participate in cross-functional investigations to determine root causes, assess product impact, determine path forward, and develop/ implement CAPAs. 

• Implement and support formulation, process, and specification improvements; implement cost reduction initiatives such as scale-up/scale-down, site transfers, and alternate APIs; and participate in project or issue-based teams.

• Execute assigned project deliverables with moderate guidance from functional management and/or Senior Process Engineers; may require guidance on technical aspects of processes of medium to high complexity, as well as problem solving approaches for dealing with project roadblocks (technical and/or logistic).

• Share best practices across the organization (Quality Forums, etc.).

• Liaise with Drug Regulatory Affairs (DRA) and Product Development to support documentation / answers required for response letters or deficiencies from the agency.

• Liaise with Change Management to support process changes such as API or material changes and subsequent impact to finished dosage forms.

• Meet cGMP, FDA, DEA, OSHA and other applicable regulatory and company guidelines.
• Prepare evaluation protocols/reports, validation protocols/reports, master formula cards and other documents for assigned products/projects to meet established project timelines.

• Collaborate with Product Development for development history and/or all required information to generate robust documentation.

• Develop validation strategies and documentation (e.g. protocols) based on standard approaches and critical process reviews, independently for processes of low to medium complexity, and in consultation with development partners, functional management, and/or Senior Process Engineers for complex processes; guidance from those three groups may be required for complex products/scenarios that differ from standard approaches.

• Write validation reports that document technical product knowledge in a way that facilitates future decision-making regarding process optimization or troubleshooting (e.g. by Operations and/or Lifecycle); guidance from functional management and/or Senior Process Engineers may be required to address significant process deviations (e.g. Event Assessments or issues that threaten successful completion of validation or require commitment to post-validation optimization activities) or significant deviations of analytical data from expected results (e.g. deviations that may require additional testing or post-validation monitoring).

• Create documentation (e.g. SAP Master Data, PMX production procedures, Master Manufacturing Formula) for scale-up, evaluation, transfer, and validation batch production, based on development process design parameters (e.g. formulation and processing steps) and scale-up considerations, in collaboration with product development or partners.

• Prepare Manufacturing Documentation for submission per Corporate Guidelines.

• Ensure attention to detail to documentation to ensure quality and timeliness of documents.

• Execute assigned project deliverables with moderate guidance from functional management and/or Senior Process Engineers; may require guidance on technical aspects of processes of medium to high complexity, as well as problem solving approaches for dealing with project roadblocks (technical and/or logistic).

• Share best practices across the organization.

• Perform peer review of documentation to drive right-first-time performance of department and to ensure accuracy of Technical Services documentation that is delivered to customers (e.g. Master Manufacturing Formulae, validation protocols and reports, submission documentation, etc.).

• Review process and/or product documentation (e.g. validation protocols and reports, Master Manufacturing Formula revisions, etc.) to ensure accuracy, to avoid generation of potential NOIs / EAs; identify errors in peer documentation and return for correction, and identify potential process improvements (e.g. optimization of material handling steps for roller compaction, to increase efficiency) based on experience, familiarity with Operations, and best practices (within Hikma, across the Hikma network, and/or across the pharmaceutical industry).

• Identify differences between processes outlined in Master Manufacturing Formulae and General Conventions.

• Review data and documentation (e.g. transcription of data into validation reports) to ensure accuracy against source data; identify errors in peer documentation and return for correction.

• Identify trends (e.g. decreasing content uniformity across a compression run), risks based on data comparison to specification (e.g. content uniformity is consistent but close to specification limit), and variability (e.g. sporadic low content uniformity results on individual tablets) within analytical data, and mentor and/or collaborate with Process Engineer that is leading the project to analyze the data and determine path forward.

• Share best practices across the organization; share observations from data reviews, highlight common errors, propose solutions to common errors, etc.

• Coordinate continuous improvement activities for launched products through initial commercial production phase, until transfer of launched products to lifecycle support with lifecycle team. 

• Identify product quality and process robustness optimization opportunities through analysis of product/process performance and collaboration with peer and customer groups.  Collaborate with organizational partners to support execution of these initiatives.

• Participate in and lead functional investigations and participate in cross-functional investigations to determine root causes, assess product impact, determine path forward, and develop/implement CAPAs.  Collaborate with organizational partners to support execution of these initiatives.

• Collect and analyze Operations process data.  Evaluate trends and collaborate with peers and management to develop process improvements. 

• Seek out technical solutions to improve performance including collaborating with internal and external experts. 

• Coordinate Batch Size Optimization activities (e.g. Costing Team, technical evaluations, protocols/ reports, formula card changes, PMX/SAP/ TrackWise changes etc.).

• Collaborate with Change Management to support process and raw materials changes (e.g. CMU process).

• Collaborate with Drug Regulatory Affairs (DRA) to support assessment of the regulatory impact of potential process changes, documentation of implemented process changes, and ensure regulatory compliance.

• Execute assigned project deliverables with moderate guidance from functional management and/or Senior Process Engineers; may require guidance on technical aspects of process of medium to high complexity, as well as problem solving approaches for dealing with project roadblocks (technical and/or logistic).

• Transfer launched products to lifecycle support with Lifecycle, per established processes; transfers are executed in consultation with functional management.

• Meet cGMP, FDA, DEA, OSHA and other applicable regulatory and company guidelines.

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 or higher in Chemistry, Engineering, Pharmacy, or related scientific discipline.

• Knowledge and understanding of applicable laws and regulations regarding development and manufacturing of pharmaceuticals, including cGMP, DEA, and FDA guidances.

• Knowledge of pharmaceutical production environment with emphasis on scale-up/ optimization and validation.

• Technical knowledge of pharmaceutical processing equipment.

• Knowledge of pharmaceutical formulation development.

• Knowledge of pharmaceutical development, technology transfer, or production principles and practices. 

• Critical Thinking: Ability to apply the PDCA principles (plan, do, check, act).

• Complex Problem Solving: Working knowledge of experimental methodology and design of experiments to support pharmaceutical development / process transfer / validation.  Ability to define root cause relationships, collect data, establish facts, and draw valid conclusions.

• Mechanical and technical aptitude: Demonstrated ability to learn functionality and troubleshooting of pharmaceutical manufacturing equipment, and understanding of the impact of critical equipment parameters on key product performance parameters at the expert level.

• Project Management: Organizational skills and ability to facilitate execution of project milestones through the use of project management skills.

• Initiative:  Works under direct supervision for strategic decisions with minimal supervision for tactical execution of tasks of moderate complexity.  Exercises moderate latitude in determining objectives and approaches to assignments.

• Teamwork: Ability to be an active participant on teams of moderate to high complexity, and to lead / facilitate teams on tasks of moderate complexity.

• Training: Skills to effectively educate colleagues on technical principles, process fundamentals, etc. (e.g. explaining critical process issues at PC meetings).

Preferred Qualifications:

• 1-3 years of experience in pharmaceutical production environment.

• Proficient knowledge and understanding of applicable laws and regulations regarding development and manufacturing of pharmaceuticals, including cGMP, DEA, and FDA guidances.

• Demonstrated knowledge of pharmaceutical production environment with emphasis on scale-up / optimization and validation.

• Demonstrated technical knowledge of pharmaceutical processing equipment.

• Knowledge of pharmaceutical formulation development.

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.

What We Offer*:

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay.  Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date).  Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

 *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment.  Benefits are subject to change as well as specific plan or program terms.

Recruiters:

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions.  In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.