Process Engineer
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Job Location:
West Point, UT - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
The Process Engineer (PE) has the responsibility to:
- Author and review GMP documentation for example:
- Standard Operating Procedures (SOPs)
- Batch record modules
- Technical Protocols reports or position papers
- Executable batch records
- Provide support to the process team in the formulation and filling of clinical liquid drug product supplies.
- PE support includes (but is not limited to): pre-execution readiness activities (label generation generating summary of components & assemblies required for manufacture authoring or issuance of batch documentation) sample delivery and clinical product delivery.
- Review executed batch documentation for adherence to good manufacturing practices and batch instruction
- Own change control records for equipment or process changes; PE must effectively collaborate with stakeholders to assess impact identify deliverables and manage change implementation.
- Perform deviation management including authoring of events assessment of impact investigation of root cause and identification of corrective & preventative actions.
- Drive process improvement projects in documentation knowledge management or shopfloor related activities.
- Qualify for aseptic gowning as required per assigned work.
This role is on-site 5 days/week
Qualifications :
Basic Minimum Qualifications:
- Bachelors/Masters degree in engineering biomedical engineering chemistry biology or related field
- Minimum of 2 years in a technical or operations support role
- Knowledge of Good Manufacturing Practices
- A drivers license which is valid within the United States
- Authorization to work in the United States indefinitely without restriction or sponsorship
Preferred Qualifications:
- Experience with project management change control or deviation management
- Experience with sterile process manufacturing and/or formulation development
- Analytical problem solving skills
- Cross-functional leadership skills
- Strong technical writing skills and have experience with batch documentation investigations and/or protocols
Additional Information :
This position is Full-Time Monday-Friday for 40 hours a week (core hours 9am to 3pm - 8hrs per day expected around core hours) on site at West Point PA with over time as needed. Candidates currently living within a commutable distance of West Point PA are encouraged to apply.
- Excellent full time benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Lean Manufacturing
- Six Sigma
- Distributed Control Systems
- Continuous Improvement
- Process Improvement
- Minitab
- Root cause Analysis
- Process Engineering
- cGMP
- Kaizen
- Programmable Logic Controllers
- Manufacturing
About Company
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more
