Title:  Sr. Process Engineer - Technical Services

Job Title:     Sr. Process Engineer - Technical Services

Location:     Columbus, Ohio

Job Type:     Full time

Req ID:         9740

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 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 global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

Description:

We continue to be 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 - Technical Services.  

In this role, you will be responsible for Leading the Registration/ Process Validation (Process Design, Process performance qualification, & Continuous Process Verification)/ Process transfer of in-house products (on-site development/ transferred or procured filings/ re-launch etc.) and champion cross coordination with multiple groups and alignment with Hikma’s quality/ compliance requirements.  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.  Developing and executing production strategies (e.g batch record documentation, GMP systems set-up etc.) for evaluation, scale-up, process validation, site transfer (in/out), and lifecycle products of multiple dosage forms (solids, non-solids, semi-solids, nasals, inhalation,  etc.).  Coordinating agency (e.g. FDA) submission documentation requirements, quality investigations, process change management, and project communications during development/ transfer/ launch/ life-cycle projects.  Mentoring junior process engineers and share best practices within Technical Services to continuously grow talent and enhance productivity.

Key Responsibilities:

1. 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.

2. 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. 

3. 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.  

4. 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.  
• Other duties as assigned

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 implementation knowledge of applicable laws and regulations regarding development and manufacturing of pharmaceuticals, including FDA, cGMP, DEA, OSHA and other applicable regulatory and company guidelines.
• Expert knowledge of pharmaceutical formulation development, processing equipment, quality by design, and cGMP production with emphasis on scale-up/ optimization and validation.
• Demonstrated ability to develop, scale-up, and/or validate pharmaceutical processes for unique and challenging dosage forms (e.g. tablets, capsules, combination products (nasals, dry powder inhalation etc.), creams/ ointments, soft gels, transdermal etc.); Demonstrate strong learning agility towards process technologies that are outside of previous experience.
• Ability to travel (domestically and internationally) to external organizations/ companies for multiple days to support project deliverables. 
• Attention to detail to documentation to ensure quality and accuracy.
• Conflict Management: Demonstrated ability to work with professionals/ teams with differing perspectives from external/ contract organizations from different regions (domestic and international) and achieve mutually acceptable solutions.
• Experimental Methodology: Demonstrated ability to design complex experiments to support pharmaceutical development/process transfer/validation. 
• Complex Problem Solving: Expert knowledge of and ability to apply investigative techniques to uncover problem areas, determine root causes, and drive corrective actions at both the individual and cross-functional team level. 
• Situational leadership: Demonstrated ability to independently work with no or minimal supervision to make strategic decisions and execute tactical tasks of high complexity. 
• Teamwork: Demonstrated ability to be an influencing participant on teams of high complexity, and to lead/facilitate teams on tasks of high complexity.

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.

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.