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Process Engineer - Manufacturing, Production & Operations - Marietta, GA


Position Overview


The Process Engineer will be responsible for process engineering and project engineering in an Oral Solid Dose Pharmaceutical manufacturing environment by providing engineering expertise for installation, startup and operation and optimization of new and existing processes. This role will help us ensure that we have robust, compliant, and efficient manufacturing processes. 

Duties and Responsibilities

  • Standardize our existing manufacturing processes (both equipment and steps) to increase robustness and compliance.
  • Develop and implement product manufacturing process improvements for existing processes.
  • Troubleshoot and resolve manufacturing process problems—determining root cause and corrective actions.
  • Develop process documentation and training material to support the standardized processes and new product launches.
  • Provide requested documentation to support compliance requirements for existing products and for new product regulatory filings
  • Provide process engineering recommendations to R&D during the development phases to ensure development of new products that can be manufactured robustly as the current level of existing technology.
  • Provide process engineering recommendations to R&D and Manufacturing on compliance and product quality during the development phase, through to ongoing commercial operations.
  • Working as a member or leader of the technology transfer team, transition new products into production to ensure that the new product meets production, quality, and compliance requirements
  • Serve as Subject Matter Expert and Trainer for key manufacturing processes
  • Provides manufacturing process leadership through process improvement and optimization
  • Initiate and conducts validation of production processes and test equipment
  • Identify quality issues and manage resolutions
  • Resolve non-conforming material issues and coordinate corrective measures
  • Review and recommend equipment for capital expenditures, generating appropriate CAPEX requests
  • Developing Engineering Preventative Maintenance Forms, Engineering Standards, Training Materials, Standard 
    Operating Procedures, and Batch Records relating to new technology introductions. 
  • Capable of reading, using, and creating engineering drawings using AutoCAD.
  • Leads new project and capital project work and installation/implementation/qualification of new equipment, 
    facilities and processes. 
  • Responsible for creating and delivering training materials to mechanics, production technicians and users for new technology. 
  • Responsible for working with the Original Equipment Manufacturers (OEM) to acquire expert knowledge for transfer internally and personal growth. 
  • Leading the implementation of new equipment, policies and/or procedures. 
  • Works on highly complex problems where analysis requires evaluation of multiple factors.
  • Exercises independent judgment in developing methods, techniques and evaluation criteria.
  • Demonstrates success in technical proficiency, scientific creativity, 
    collaboration with others and independent thought. 
  • Coordinates activities with Manufacturing and Pharmaceuticals technology teams to ensure proper prioritization. 
  • Designs and interprets technical studies and data in order to resolve technical issues encountered during each 
    project. Helps to define technical objectives and to convey them to the other members of the project team. 
  • Determines approaches to be utilized for assigned projects, then plans and executes work independently with minimal supervision.

Experience and Qualifications

  • Bachelor’s Degree in an Engineering Discipline required
  • At least three (3) years of demonstrated increasing responsibility in a pharmaceutical cGMP environment or the equivalent required.
  • Ability to lead hourly associates as required
  • Prior experience in an FDA regulated industry required
  • Previous experience using AutoCAD software
  • Prior experience using lean and six sigma principles and tools.
  • Ability to travel up to 10% of time.
  • Functions well as a team member – is highly reliable and committed
  • Understanding of pharmaceutical manufacturing processes and equipment required
  • Must possess strong communication skills, written and oral
  • Working knowledge of cGMP’s
  • Problem Analysis and Resolution
  • Planning and Organization
  • Must have practical working knowledge of engineering disciplines (e.g. fluid flow, thermodynamics, heat transfer and engineering materials.)
  • Can operate with little supervision; must be self-motivated and largely self-directed

About Us

Osmotica Pharmaceuticals is a global specialty pharmaceutical company with a proven history of developing commercially successful pharmaceutical products using a proprietary osmotic technology platform.  In February 2016, Osmotica Pharmaceuticals combined with Vertical Pharmaceuticals, LLC and Trigen Laboratories, LLC to create a world-class, fully-integrated specialty pharmaceutical and generics company.

Vertical Pharmaceuticals, LLC was founded in 2003 with a mission to develop, market, and acquire products offering therapeutic benefits for patients and healthcare providers. Vertical Pharmaceuticals supplies branded prescription products, specializing in Neuroscience and Women’s Health with brands such as Lorzone®, Divigel®, and OB Complete®.

Trigen Laboratories, LLC is a generic pharmaceutical company offering unique products across an increasing array of categories. Trigen seeks to bring value-driven generic products to its customers, working vigorously with its partners to identify and develop products which face an assortment of challenges. Additionally, Trigen identifies unique marketing opportunities and is steadfast in its pursuit to deliver products to best serve these markets.

All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, disability or veteran status.



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Brian Markison, Chairman of the Board and Chief Executive Officer

Brian Markison has served as Chairman of the Board and Chief Executive Officer of Osmotica since 2016. Mr. Markison is a healthcare industry veteran, with more than 30 years of operational, marketing, commercial development and sales experience with international pharmaceutical companies. He has served as an advisor to Avista Capital Partners since September 2012. He previously served as the President, Chief Executive Officer and board member of Fougera Pharmaceuticals, Inc., a dermatology-focused specialty pharmaceutical company sold to Sandoz Ltd., the generics division of Novartis AG. Before leading Fougera, Mr. Markison was Chairman and Chief Executive Officer of King Pharmaceuticals, Inc., which he joined as Chief Operating Officer in March 2004. He was promoted to President and Chief Executive Officer later that year and elected Chairman in 2007. Prior to joining King Pharmaceuticals, Inc., Mr. Markison held various senior leadership positions at Bristol-Myers Squibb. He serves as Chairman of the Board of Lantheus Holdings, Inc. and is on the board of directors of Avista Healthcare Public Acquisition Corp., National Spine and Pain Centers, LLC and Braeburn Pharmaceuticals, Inc. He is also a Director of the College of New Jersey.

James Schaub, Executive Vice President and Chief Operating Officer

James Schaub has served as our Executive Vice President and Chief Operating Officer since 2016. Mr. Schaub previously served as Chief Operating Officer of Trigen Laboratories and as Vice President of M&A at Fougera Pharmaceuticals, Inc. He also held several commercial roles of increasing responsibility at King Pharmaceuticals, Inc. Mr. Schaub is a graduate of Middlebury College and holds an M.B.A. from Rutgers Business School.

Andrew Einhorn, Chief Financial Officer

Andrew Einhorn joined as Chief Financial Officer in September 2017. Mr. Einhorn has more than 15 years of experience in the pharmaceutical industry. Mr. Einhorn previously served as the Chief Financial Officer of Edge Therapeutics, Inc., a clinical-stage biotechnology company that he joined as Executive Vice President of Corporate Development in 2013. Prior to that, he was a co-founder, Executive Vice President and Chief Financial Officer at Oceana Therapeutics, Inc. Previously, Mr. Einhorn was a co-founder and Chief Financial Officer of both Esprit Pharma, Inc. and ESP Pharma, Inc. Mr. Einhorn is licensed as a Certified Public Accountant in the State of New Jersey and holds a B.S. in Finance and Accounting from American University.

Christopher Klein, J.D., General Counsel and Secretary

Christopher Klein has served as our General Counsel and Secretary since December 2013. Mr. Klein previously served as the General Counsel of Fougera Pharmaceuticals, Inc. and as Deputy General Counsel at King Pharmaceuticals, Inc. Mr. Klein spent six years in senior legal roles with Bristol-Myers Squibb Company. Mr. Klein holds a B.A. in Biology from Adelphi University, an M.A. in Education from Columbia University and a J.D. from Fordham University.

Tina deVries, Ph.D., Executive Vice President, Research and Development

Tina deVries, Ph.D. became our Executive Vice President, Research & Development in May 2016. Dr. deVries most recently served as the Principal of TM deVries Consulting, LLC. She was previously Vice President of Nonclinical and Clinical Pharmacology at Actavis plc following its 2013 acquisition of Warner Chilcott plc where she served as the Vice President of Clinical Pharmacology. Dr. deVries holds a B.S. in Pharmacy and a Ph.D. in Pharmaceutics and Pharmaceutical Chemistry from Ohio State University.

Lynn Franklin Palmer, Senior Vice President, Technical Operations

Lynn Palmer has served as our Senior Vice-President, Technical Operations since June 2017. Prior to that, he served as Vice-President, Manufacturing from February of 2016. Before Osmotica, Mr. Palmer served as Executive-Vice-President, Engineering at King Pharmaceuticals for six years. Previously Mr. Palmer led Engineering at Mallinckrodt Inc. (a division of Tyco Healthcare), and served as Vice-President, Production at Inbrand Corporation. Prior to Inbrand, he served in progressive manufacturing management roles at Kimberly-Clark Corporation from 1982-1996. Mr. Palmer holds a Bachelor of Applied Science in Paper Science and Engineering from Miami University.

Jarret Miller, Executive Vice President, Human Resources

Jarret Miller has served as our Executive Vice President, Human Resources since January 2016. Mr. Miller has more than 20 years of Human Resources experience in various roles of increasing responsibility. He previously served as the Head of Human Resources Operations and Services for the Americas at Teva Pharmaceuticals, Inc. Prior to that, he held the positions of Vice President, Human Resources at ConvaTec, Inc. and Senior Vice President, Human Resources at King Pharmaceuticals, Inc. Mr. Miller holds a B.S. in Statistics and Biometry from Cornell University.

David Burgstahler

David Burgstahler has been a director since 2016. Mr. Burgstahler is the President and Co-Managing Partner of Avista Capital Partners and is the Chief Executive Officer of Avista Healthcare Public Acquisition Corp. Mr. Burgstahler was a founding partner of Avista Capital Partners in 2005 and since 2009, has been President of Avista Capital Partners. Prior to forming Avista Capital Partners, Mr. Burgstahler was a partner of DLJ Merchant Banking Partners. Previously, Mr. Burgstahler worked at Andersen Consulting (now known as Accenture plc) and McDonnell Douglas (now known as The Boeing Company). Mr. Burgstahler currently serves as a director of Avista Healthcare Public Acquisition Corp., Inform Diagnostics, Inc., Kramer Laboratories, Inc., United BioSource Corporation and WideOpenWest, Inc. He is also a Trustee of the Trinity School in New York City. Mr. Burgstahler holds a B.S. in Aerospace Engineering from the University of Kansas and an M.B.A. from Harvard Business School.

Sriram Venkataraman

Sriram Venkataraman has been a director since 2016. He is a Partner of Avista Capital Partners, having joined in 2007. Prior to joining Avista Capital Partners, Mr. Venkataraman was a Vice President in the Healthcare Investment Banking group at Credit Suisse Group AG. Previously, he worked at GE Healthcare (formerly known as GE Medical Systems). He currently serves as a director of OptiNose, Inc., Inform Diagnostics, Inc. and National Spine & Pain Centers Holdings, LLC and previously served as a director of AngioDynamics, Inc., Lantheus Holdings, Inc. and Zest Anchors, Inc. Mr. Venkataraman holds an M.S. in Electrical Engineering from the University of Illinois, Urbana-Champaign and an M.B.A. from The Wharton School at the University of Pennsylvania.

Daniel Sielecki

Daniel Sielecki became a director of Osmotica Holdings Corp Ltd. in 2007 and joined the board of directors in 2016 in connection with the combination of Osmotica Holdings Corp Ltd. and Vertical/Trigen. Mr. Sielecki has worked at Laboratorios Phoenix S.A since 1975 and currently serves as a director of Simali S.A., Petroquımica Cuyo S.A and PEPCA S.A. He previously served as a director of Disprofarma S.A.

Carlos Sielecki

Carlos Sielecki became a director of Osmotica Holdings Corp Ltd. in 2007 and joined the board of directors in 2016 in connection with the combination of Osmotica Holdings Corp Ltd. and Vertical/Trigen. Mr. Sielecki currently serves as a director of Simali S.A. and holds a degree in architecture from the University of Buenos Aires.

Juan Vergez

Juan Vergez became a director in 2016. Mr. Vergez served as the President of Osmotica Argentina from November 2010 to May 2016, and as the New Business Director of Osmotica Argentina from May 2016 to December 2017. Mr. Vergez previously served as a director of Nutrifoods, S.A. and has more than 40 years of experience in the pharmaceutical industry.

Sergio Alegre

Sergio Alegre became our Vice President of Global Compliance in August of 2016. Mr. Alegre previously served as Executive Director of Pacira Pharmaceuticals, Inc., where he implemented and oversaw its Compliance Program from August 2012 to August 2016. In addition, he spent seven years as Vice President of Mergers and Acquisitions for Realogy Corporation, following a time in private practice at a law firm in New York City. He holds a B.A. in Political Science and History from Rutgers University and a J.D. from Fordham University School of Law.