Technical Operations Internship - Summer
Create a free account to apply in seconds
Careers at Alcresta Therapeutics
Technical Operations Internship - Summer
Alcresta Therapeutics develops novel products that deliver enzymatic solutions to those living with rare diseases. Based in Waltham, Massachusetts, Alcresta Therapeutics has achieved significant commercial milestones, created an extensive intellectual property portfolio, optimized production capabilities, and developed exciting scientific data supporting its products and technology platform. For additional information, please visit www.alcresta.com.
We are seeking summer interns interested in learning about medical device development, qualification and commercialization while actively contributing to the commercialization of new enzyme-based products to address unmet patient needs. Under the supervision of an experienced mentor, the qualified candidate will engage in a range of equipment and process qualification activities at a Contract Design Manufacturing Organization (CDMO) , such as: Process inputs ranging and engineering studies, automation and manual equipment validations, Technical documentation related to qualification protocols and accompanying reports, and collaboration with engineers in a regulated medical device operations environment.
Key activities:
• Use of technical skills in support of team driven root cause investigations.
• May support commercial production across the supply network in disposition of non-conformances and other issues that may impact patient safety.
• Engineering support for Quality requirements as outlined in FDA 21 CFR Part 820 – Quality systems.
• Document Controls – Design documents are maintained in Alcresta’s document control system.
• Process Controls – Control Plans, Inspection points, accept / reject decisions are robust.
• Identification and traceability – Understanding of Bill Of Materials and Routers.
• Provide on-site manufacturing support at the CMO 0-5 days per week, local to Boston
• Team member of technology transfer operations team; supporting equipment installations, process validations and test method validations to ensure a robust capable process.
• Foster a positive environment and a culture of continuous improvement and teamwork.
Education/Experience:
• Must be pursuing an Associate’s, Bachelor’s, or Master’s degree in Engineering discipline or similar with a 3.0 GPA or higher
Skills/Competencies:
• Willingness to work in a start-up style environment, including a “roll-up-the-sleeves” attitude
• Detail oriented, with good written and verbal communication skills
• Strong team player, results-oriented, and capable of working in a fast-paced, changing environment
• Ability to manage multiple tasks with a focus on long-term goals and timelines, effectively balances team and individual responsibilities
• Self-motivated, creative, and organized
• Good knowledge of Microsoft Office tools (Outlook, Word, Excel, PowerPoint, etc.)
• Exposure to injection molded components is a plus.
• Logical, with adept problem-solving skills.
• Familiarity with Minitab and statistical techniques is a plus.
Additional information:
• Summer internship; typically 10-12 weeks, beginning and end to be determined by availability
• 40 hours/week
• Candidates must be able to successfully pass background and drug screen investigations.
• Main Office Located in Waltham, Massachusetts
• Travel to Mansfield, Massachusetts 2-3 days per week, with 1-2 days remote work opportunity pending deliverables.
Anticipated hourly rate: $18-$20