Planet Pharma
Job Description
Target PR Range: 25-35/hr *Depending on experience
In this role, the candidate will work cross functionally supporting tech transfer activities for clinical and commercial with CMO sites, getting exposure to the FDP manufacturing processes for automated and HMLV (high mix low volume) processes for combination products (device assembly, labeling, and packaging). This includes identifying and exploring technologies in partnership with site PD, NPI lead, Validation Engineering, and Project Management.
Key Responsibilities: • Support Tech Transfer activities • Lead process gap assessment exercises • Generate PTD (Process Transfer Document) • Manage dashboards by updating KPI status and timelines • Support characterization and PPQ activities at the receiving site • Perform forensic analysis of devices • Conduct root cause analysis using standard methodologies • Leverage automation skillset to access and analyze equipment data • Program within statistical analysis software or data tools such as MATLAB • Update and optimize equipment automation recipes for quality, rapid device assembly • Support design of test fixtures and/or assembly tools for manufacturing • Troubleshoot device and equipment failure
This position is on site and might require to travel depending on the project/program needs.
Basic Qualifications: Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience
Ideal Qualifications: • Engineering or biotechnology background • Enthusiasm for new technology (digital and mechanical) • Continuous improvement mindset • Clear communication and presentation skills
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Target PR Range: 25-35/hr *Depending on experience
In this role, the candidate will work cross functionally supporting tech transfer activities for clinical and commercial with CMO sites, getting exposure to the FDP manufacturing processes for automated and HMLV (high mix low volume) processes for combination products (device assembly, labeling, and packaging). This includes identifying and exploring technologies in partnership with site PD, NPI lead, Validation Engineering, and Project Management.
Key Responsibilities: • Support Tech Transfer activities • Lead process gap assessment exercises • Generate PTD (Process Transfer Document) • Manage dashboards by updating KPI status and timelines • Support characterization and PPQ activities at the receiving site • Perform forensic analysis of devices • Conduct root cause analysis using standard methodologies • Leverage automation skillset to access and analyze equipment data • Program within statistical analysis software or data tools such as MATLAB • Update and optimize equipment automation recipes for quality, rapid device assembly • Support design of test fixtures and/or assembly tools for manufacturing • Troubleshoot device and equipment failure
This position is on site and might require to travel depending on the project/program needs.
Basic Qualifications: Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience
Ideal Qualifications: • Engineering or biotechnology background • Enthusiasm for new technology (digital and mechanical) • Continuous improvement mindset • Clear communication and presentation skills
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.