Senior Project/Process Engineer
| Job Type | Permanent |
| Location | Boston, MA |
| Area | USA, USA |
| Market | Life SciencesLife Sciences - Engineering |
| Salary | Competitive |
| Currency | GBP |
| Start Date | |
| Advertiser | Courtney Robb |
| Job Ref | MG-5624 |
- Description
- Senior Project/Process Engineer (BioPharma)
Location – Greater Boston, MA
Daksta are currently working with a leading engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. The company is a leader of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.
Their services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.
The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.
Responsibilities
The role entails the primary job functions:
- Responsible for generating and tracking performance metrics.
- Executes engineering tasks and deliverables within schedule and budget constraints.
- Liaising with our client's management to ensure a productive and professional working relationship.
- Maintains knowledge of current good manufacturing practices cGMPs.
- Regularly working on site, located in Boston, MA.
- Strong interpersonal, written and oral communication skills.
- Contributes and supports high-performance, cross-functional teams.
- Follows site specific work instructions, policies and procedures.
- Functions as a technical expert on process equipment or systems.
- Analyzes and documents production data using standard scientific methods.
- Leads troubleshooting of operations and generates corrective actions preventive actions CAPAs.
- Works on multiple projects or tasks of moderate scope and complexity as a team member, requiring minimal supervision.
Qualifications
- Requires a bachelor’s or master’s degree in Mechanical Engineering, Chemical Engineering or Biochemical Engineering. 7-10+ years of experience in the biotech-pharmaceutical academic or industrial environment.
- Knowledge of drug substance manufacturing.
- Basic knowledge of regulatory compliance inclusive of cGMP, OSHA, EPA, FDA regulations. Familiarity with ICH guidelines and EMA regulations is a plus.
- Technical writing with proficiency in Excel, PowerPoint, Visio, Word, Sharepoint, etc. in addition to experience working within shared work environments.
- Demonstrated experience with facilities systems and/or manufacturing processes and equipment used in pharmaceutical and biotech manufacturing.
- Basic knowledge of the Commissioning and Qualification.
- Boston area based
Candidates please note: Kindly ONLY apply if you meet the experience expectations described: Experience in GMP pharmaceutical and/or biotechnology facilities in design, engineering, quality or manufacturing is a MUST. Interested candidates with direct related experience in US or Toronto locations are encouraged to apply.
Salary range in US Dollars
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