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- Tasks: Lead maintenance and preventive care for clinical manufacturing equipment in a dynamic environment.
- Company: Join Alkermes, a global biopharmaceutical leader dedicated to improving lives through innovative medicines.
- Benefits: Enjoy a supportive culture, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare while working with cutting-edge technology and a diverse team.
- Qualifications: 5+ years of experience with Oral Solid Dose equipment and a technical degree preferred.
- Other info: Onsite role in Waltham with on-call duties; great for hands-on problem solvers!
The predicted salary is between 44000 - 66000 £ per year.
An advanced level technician position primarily responsible for general maintenance and preventive maintenance activities of our Oral Solid Dose clinical manufacturing equipment. The role will operate under limited direct supervision and is charged with keeping the equipment within operational specifications and safe.
Essential duties include:
- Corrective and preventive maintenance of the OSD equipment.
- Designing and recommending equipment purchases.
- Writing and executing equipment specification and commissioning protocols.
- Assisting with troubleshooting, identification, and implementation of process/equipment improvements to reduce waste and increase process reliability.
- Assuring the resolution of deviations, corrective actions, action items from Change Control systems, and any audit non-compliance items.
- Performing process and equipment evaluation to identify risks and weaknesses in new and current processes.
This is an onsite role in our Waltham facility.
KEY DUTIES:
- Perform PM’s and follow written preventative maintenance procedures.
- Accurately complete maintenance paperwork, including work orders and logbooks.
- Supervise and review the work performed by others.
- Review and update maintenance procedures based on field experience.
- Review and update drawings to reflect as-built conditions.
- Identify opportunities for improving the PM program.
- Recommend changes to the PM program based on experience with equipment and analysis of historical data.
- Accept ownership of selected equipment and serve as point person for repairs/PM.
- Train fellow mechanics on technical details.
- Identify critical spare parts based on field experience.
- Respond to customer requests and/or alarm conditions.
- Assess breakdowns, systematically identify problems, and restore to operation.
- Accurately document repair activities.
- Support Quality Assurance investigations of breakdowns.
- Supervise contractors performing tasks within the building.
- Ensure that contractor employees follow Alkermes safety and cGMP standards.
- Oversee technical quality of work performed.
- Identify facility/utility improvement projects, develop scope and estimates, and manage small projects.
- Respond to a variety of problems that may occur.
- On-call duties responding to emergencies 24 hours/day, usually one week out of every six.
Qualifications
Knowledge/Skills Needed:
- Superior mechanical aptitude.
- Good pipe fitting, plumbing, and industrial maintenance skills.
- Good knowledge of rotating machinery (pumps, fans, blowers).
- Thorough mechanical/electrical engineering knowledge as it applies to general process systems and equipment.
- Knowledge of automated control systems.
- Knowledge of computer systems operation and software.
- Thorough knowledge of cGMP, OSHA, EPA, and FDA facility requirements and regulations.
- Knowledge of chemistry, statistics, equipment design, process control, and process scale-up.
- Hands-on ability to install and troubleshoot instrumentation and equipment.
- Ability to troubleshoot and maintain manufacturing systems, equipment, and processes.
- Ability to author high-quality technical protocols/reports.
- Ability to specify and size manufacturing systems, equipment, and process equipment.
- Ability to read, understand, and accurately follow company SOPs and guidelines.
- Familiarity with OSD companies such as Korsch, Glatt, Freund Vector, Syntegon, Netzsch, and Gerteis.
BASIC QUALIFICATIONS:
- 5+ years of Oral Solid Dose equipment experience, such as Tablet Press, Coating, Blender, Mill (Mandatory).
- 10+ years of pharmaceutical experience.
- Seven to fifteen years of maintenance experience.
- Two-year technical degree or trade school (BS degree preferred).
PREFERRED QUALIFICATIONS:
- Ability to lift/move 40 lbs. overhead.
- Must be able to be medically cleared for respirator use (PAPR).
- Ability to operate different types of production equipment.
- Ability to gown correctly for clean room manufacturing operations.
- Ability to stand or sit for extended periods (up to 4 hours at a time).
- Must be able to work in an office and a manufacturing environment.
- Some travel required.
Lead Maintenance Technician- OSD employer: Alkermes
Contact Detail:
Alkermes Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Lead Maintenance Technician- OSD
✨Tip Number 1
Familiarise yourself with the specific equipment mentioned in the job description, such as Tablet Press and Coating machines. Understanding their operation and maintenance will give you an edge during interviews.
✨Tip Number 2
Highlight your hands-on experience with preventive maintenance and troubleshooting. Be prepared to discuss specific examples where you've successfully resolved equipment issues or improved processes.
✨Tip Number 3
Research Alkermes' culture and values, especially their commitment to diversity and inclusion. Being able to articulate how your personal values align with theirs can make a strong impression.
✨Tip Number 4
Network with current or former employees of Alkermes if possible. They can provide insights into the company culture and expectations, which can be invaluable during your application process.
We think you need these skills to ace Lead Maintenance Technician- OSD
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in maintenance and preventive maintenance, especially with Oral Solid Dose equipment. Use specific examples that demonstrate your mechanical aptitude and familiarity with the required machinery.
Craft a Strong Cover Letter: In your cover letter, express your passion for the role and the company. Mention your experience in the pharmaceutical industry and how it aligns with Alkermes' mission. Be sure to include specific achievements that showcase your skills in troubleshooting and process improvements.
Highlight Technical Skills: Clearly outline your technical skills related to mechanical and electrical engineering, as well as your knowledge of cGMP and FDA regulations. This will help demonstrate your capability to perform the essential duties of the role effectively.
Proofread Your Application: Before submitting, carefully proofread your application materials. Look for any spelling or grammatical errors, and ensure that all information is accurate and clearly presented. A polished application reflects your attention to detail, which is crucial for this role.
How to prepare for a job interview at Alkermes
✨Showcase Your Technical Expertise
Make sure to highlight your experience with Oral Solid Dose equipment, such as Tablet Presses and Blenders. Be prepared to discuss specific maintenance tasks you've performed and how they relate to the role at Alkermes.
✨Demonstrate Problem-Solving Skills
Prepare examples of how you've successfully troubleshot equipment issues in the past. Discuss your systematic approach to identifying problems and restoring operations, as this is crucial for the Lead Maintenance Technician position.
✨Familiarise Yourself with cGMP Standards
Since compliance with cGMP, OSHA, and FDA regulations is essential, brush up on these standards. Be ready to explain how you have ensured compliance in previous roles and how you would apply this knowledge at Alkermes.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's maintenance procedures and any ongoing projects. This shows your genuine interest in the role and helps you understand how you can contribute to the team effectively.
