Planet Pharma · 21 hours ago
Process Engineer II
Riverview, FL
Full-time
Onsite
Entry, Mid Level
$35/hr - $45/hr
2+ years expPlanet Pharma is a company focused on process engineering within the medical manufacturing industry. They are seeking a Process Engineer II to analyze supplier and in-house processes, drive process improvements, and manage project timelines while ensuring compliance with FDA regulations and GMPs.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Process Engineering is responsible for analyzing and assessing supplier and in-house processes to determine process capability
Identify and drive process improvements
Support supplier assessment and selection process
Employee will work with the implementation of new product development and process implementations
The documentation/qualification activities include but not limited to: feasibility studies, validation protocols, standard operating procedures changes, training material, drawings, raw material specifications updates etc
This resource will manage the site timeline for the project and will participate in the project management activities
This contractor will engage with suppliers and manage all external responsibilities
Design and develop processes and equipment to improve productivity
Provide process control measures through validation plans, data analysis, and statistical process control techniques
Documentation and communication skills to manage projects, vendors, test plans, and present cost justifiable action plans and reports
Organizational skills to manage/prioritize task assignments, amongst unplanned troubleshooting tasks
Maintain a clean and safe work environment for self and others
Display a sense of urgency, sound judgment, and pride in workmanship
Display self-motivation and the ability to work independently and as part of team
Utilize upward communication to keep supervisor informed of task status, job-related problems and other information related to work activity
Understanding of FDA regulations surrounding the manufacture of medical devices, GMPs, and process validations
Experience with change documentation package
Statistical analysis and feasibility studies for new process
Ability to write clear and concise Test Protocols and Procedures
Good written and verbal skills
Self driven individual and result-oriented person
Experience with manufacturing environment and automated machines. Pharmaceutical experience is considered a plus
Knowledge of modern computer programs to include project management software
Strong Computer skills & MS office suite (Excel, Word, Project etc.)
Ability to express ideas both in written and oral communications
Ability to coordinate with different people who have different priorities and agendas to accomplish the task at hand
Ability to deal with contractors in order to assist them with the equipment process commissioning
Excellent interpersonal and reasoning skills
Knowledge of design engineering tools such as AutoCAD, standard machine shop processes, and specialty shop capabilities
Follow all certified standards, GMP, OSHA, plant policies and procedures
Sets the standard for timeliness, work ethic, and personal integrity
Positive attitude, result-oriented person
Ability to manage multiple task in a high paced environment and willing to adapt and address scope changes
Qualification
Required
Understanding of FDA regulations surrounding the manufacture of medical devices, GMPs, and process validations
Experience with change documentation package
Statistical analysis and feasibility studies for new process
Ability to write clear and concise Test Protocols and Procedures
Good written and verbal skills
Self driven individual and result-oriented person
Experience with manufacturing environment and automated machines
Knowledge of modern computer programs to include project management software
Strong Computer skills & MS office suite (Excel, Word, Project etc.)
Ability to express ideas both in written and oral communications
Ability to coordinate with different people who have different priorities and agendas to accomplish the task at hand
Ability to deal with contractors in order to assist them with the equipment process commissioning
Excellent interpersonal and reasoning skills
Knowledge of design engineering tools such as AutoCAD, standard machine shop processes, and specialty shop capabilities
Follow all certified standards, GMP, OSHA, plant policies and procedures
Sets the standard for timeliness, work ethic, and personal integrity
Positive attitude, result-oriented person
Ability to manage multiple task in a high paced environment and willing to adapt and address scope changes
Education required/ preferred: B.S. Mechanical or Electrical Engineering
Minimum 2 years of experience preferably in a medical manufacturing industry
Strong technical expertise on manufacturing equipment and process
Project management experience Manufacturing equipment validation, Documentation updates
Preferred
Experience with printing systems and labeling management systems
Experience using Microsoft Office Software, Agile, Minitab or equivalent QMS/statistical analysis software
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase