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Sr. Manager Process Engineering

OcyonBio PR INC
00603, PR
  • Posted: over a month ago
  • Full-Time
Job Description

The Company

OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies.

OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications. Manufacturing and development spaces are designed to be autonomous while being interconnected to systems required to support clinical and commercial requirements.

We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued. The character of our employees is as important as their talent, and we’re proud of the team and environment we’re assembling as we grow.

Place of Performance: CII George Sanders, Aguadilla Pueblo, Aguadilla P.R. 00603.

The Role: We are looking to add a Sr. Manager Process Engineering to the Engineering team who will be accountable to ensure appropriate equipment and technologies are designed and controlled to enable reliable manufacturing processes of sterile product, including but not limited to: aseptic filling, and closing systems, cleaning and sterilization processes, including steam sterilization of components, terminal sterilization, and vapor hydrogen peroxide, formulation and dispensing processes. We have a strong internal team and looking to add a forward thinker and problem-solver who understands the unique needs of a growing professional services business.

Duties and responsibilities:

  • Provides direction and serves as a primary technical resource to identify enabling technologies for parenteral manufacturing.
  • Ensures equipment solutions are designed, procured, validated, and controlled to maintain process robustness as defined in the User Requirement Specifications, and to support control of existing manufacturing process parameters.
  • Provides Process Expertise to the site Commissioning, Qualification, and Validation activities, This may include authoring, approval and/or execution of validation strategies for critical Unit Operations.
  • Accountable for successful validation of critical process equipment through Performance Qualification exercises, and ensures Unit Operations continually meet User Requirement Specifications, and process requirements.
  • Provides leadership shop-floor troubleshooting and root cause analysis of undesired trends or deviations related to process equipment.
  • Works with Original Equipment Manufacturers, Engineering, IT, and Manufacturing to implement accurate and timely solutions; develops and manage plans as needed.
  • Works closely with Engineering Automation and IT to ensure equipment automation and instrumentation is appropriately configured and defined to meet User Requirements, support control and measurement of process parameters, and support process monitoring and robustness activities.
  • Partners with Corporate Manufacturing Technology and Engineering groups towards identification of best process equipment solutions in industry related to pharmaceutical technology and process support to manufacturing; effective introduction to the site operational environment to create a competitive advantage.
  • Oversees application of statistical process control methodologies to ensure unit operations are operating in control.
  • Leads execution of Process Risk Assessment Exercises, such as pFMEA
  • Works with Operational Excellence, Manufacturing, and Engineering to ensure Reliability Engineering and Maintenance Programs are designed to ensure process robustness over time
  • Other duties will be assigned, as necessary.


Requirement:

  • Requires a Master’s in Mechanical, Chemical or Electrical Engineering with 8+ years’ experience
  • Strong mechanical aptitude and troubleshooting skills
  • Thorough knowledge of pharmaceutical equipment design, commissioning, qualification, and validation processes.
  • In depth knowledge of engineering tools such as Statistical Process Control, Failure Mode and Effect Analysis, and P& ID’s as necessary to complete the job requirements, and support robust operation of critical unit operations.
  • Knowledge and experience working with equipment automation systems, including both PLC and PC-based control platforms, ranging from both local controlled equipment to fully automated electronic batch record and data capture capability
  • Knowledge and experience in strategic grasp of manufacturing best practices, state of the art manufacturing technologies within area of specialty, and appropriate deployment of the same.
  • Strong time management skills, planning and organization capabilities. Mastery on project management skills.
  • Proven ability to influence and lead other engineers/contractors towards the execution of position objectives.
  • Strong communication skills are required.
  • Strong writing and communication skills and the ability to work independently.
  • High level of attention to detail, excellent verbal and written communication skills required.
  • Ability to multitask, handle changing priorities, tight deadlines, and the ability to work outside one’s comfort zone.
  • Strong mechanical aptitude and troubleshooting skills
  • Thorough knowledge of pharmaceutical equipment design, commissioning, qualification, and validation processes.
  • In depth knowledge of engineering tools such as Statistical Process Control, Failure Mode and Effect Analysis, and P& ID’s as necessary to complete the job requirements, and support robust operation of critical unit operations.
  • Knowledge and experience working with equipment automation systems, including both PLC and PC-based control platforms, ranging from both local controlled equipment to fully automated electronic batch record and data capture capability
  • Knowledge and experience in strategic grasp of manufacturing best practices, state of the art manufacturing technologies within area of specialty, and appropriate deployment of the same.
  • Strong time management skills, planning and organization capabilities. Mastery on project management skills.
  • Proven ability to influence and lead other engineers/contractors towards the execution of position objectives.
  • Demonstrates high level of maturity, self-motivation, and team-orientation.

What we offer:

  • Competitive salary (DOE).
  • Health, dental, and vision benefits.
  • Professional training and development opportunities.
  • Opportunity to participate in the company stocks options program.
Working conditions:Physical RequirementsOFFICE POSITION - While performing the duties of this job, the employee is required to:
  • Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment
  • Specific vision abilities required by this job include close vision requirements due to computer work
  • Light to moderate lifting is required
  • Moderate noise (i.e. business office with computers, phones, and printers, light traffic).
  • Ability to sit at a computer terminal for an extended period of time Sedentary work exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.

We Are An Equal Opportunity Employer

Ocyonbio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

If you want to challenge yourself, accelerate your career, and give new hope to patients, there is no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients' lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.

We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued. The character of our employees is as important as their talent, and we’re proud of the team and environment we’re assembling as we grow.

To learn more about us, please visit our website: https://ocyonbio.com

OcyonBio PR INC

Address

00603, PR
00603 USA

Industry

Manufacturing

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