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- Tasks: Lead engineering teams to enhance reliability in pharmaceutical production.
- Company: Alkermes develops innovative medicines for complex psychiatric and neurological disorders.
- Benefits: Enjoy a supportive culture, competitive salary, and recognition as a top employer.
- Why this job: Make a real impact on patient lives while working in a diverse and inclusive environment.
- Qualifications: BS in Engineering with 15 years in pharmaceutical operations required.
- Other info: Onsite position in Waltham, MA with opportunities for mentorship and leadership.
The predicted salary is between 150000 - 210000 £ per year.
Director, Engineering and Reliability Services
Join to apply for the Director, Engineering and Reliability Services role at Alkermes
Director, Engineering and Reliability Services
Join to apply for the Director, Engineering and Reliability Services role at Alkermes
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GENERAL DESCRIPTION:
A leadership position in Site Operations group responsible for Reliability Services, supporting early research through clinical production. The Director, Engineering will effectively lead, direct, and integrate cross-functional, cross-organizational, multi-disciplinary teams to meet business objectives. This is an onsite position based in our Waltham location.
Job Description
GENERAL DESCRIPTION:
A leadership position in Site Operations group responsible for Reliability Services, supporting early research through clinical production. The Director, Engineering will effectively lead, direct, and integrate cross-functional, cross-organizational, multi-disciplinary teams to meet business objectives. This is an onsite position based in our Waltham location.
Responsibilities
KEY DUTIES:
- Plans, organizes, and leads site engineering function to effectively engineer and procure necessary equipment and facilities.
- Direct appropriate qualification/validation activities within department.
- Oversight of team that supports companion Engineering dept functions in Reliability and Project Services.
- Oversight of team that serves as equipment/technical owners of equipment and utilities throughout the site.
- Oversight of team that performs the commissioning functions throughout the site.
- Contributes to site master plan and conceptual designs.
- Oversight of the development of Standard Operating Procedures for equipment and systems throughout the facility.
- Identify and implement system improvements and operational excellence activities. within department, and support OE initiatives throughout the site.
- Applies knowledge and innovation to proactively identify, communicate and implement required project/plan modifications and resolve problems.
- Remain current on industry and FDA engineering standards and trends.
- Plans and manages Reliability Services budget.
- Serve as a member of the Engineering Forum to ensure alignment and best practices.
- Oversight of Global Engineering Standards effort.
Qualifications
SKILLS/ABILITIES:
- Thorough mechanical and chemical engineering knowledge as it applies to general facility systems and equipment, and drug product facility systems and equipment.
- Thorough knowledge of electrical, electronic and instrumentation systems.
- Thorough knowledge of computer systems operation and software.
- In-depth knowledge of CGMP, OSHA, EPA and FDA facility requirements and regulations.
- General knowledge of chemistry, statistics, facility design, cost estimation, process control and process scale-up.
- General knowledge of pharmaceutical operations and equipment validations, in-depth knowledge of facility and utility validations.
- Excellent communication and documentation skills.
- \”Hands-on\” ability to troubleshoot and install mechanical, instrumentation and electrical equipment.
- Ability to troubleshoot and maintain facility systems, equipment and processes.
- Excellent people skills to supervise personnel and interact with other facility and research groups.
- Excellent writing skills to prepare engineering and validation protocols, facility reports, summary documents, equipment specifications and SOPS, and batch records.
- Ability to specify and size facility systems, equipment and process equipment.
- In-depth knowledge of internal documentation control.
BASIC QUALIFICATIONS:
EDUCATION AND EXPERIENCE:
- BS in Chemical, Electrical or Mechanical Engineering required.
- 15 years in Pharmaceutical facility operations, maintenance, ideally with Oral Solid Dose manufacturing and laboratory operation experience.
- A keen ability to coach and mentor subject matter experts; to work collaboratively and effectively manage a team.
- Experience in automation and instrumentation, validation, electrical power and electronics, clean utilities and facility design and construction required.
PREFERRED QUALIFICATIONS :
- Must have experience with structured approaches to Risk Assessment (ex. FMEA) and an understanding of pharmaceutical Quality by Design (QbD).
- Experience in Value Stream Leadership, with demonstrated leadership in the achievement of Operational Excellence.
- Financial savvy in operational cost analysis and budget management.
- Exposure to and understanding of U.S. and international regulatory standards and requirements.
- Ability to work onsite in our Waltham facility
About Us
Why join Team Alkermes?
Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.
Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
Seniority level
-
Seniority level
Director
Employment type
-
Employment type
Full-time
Job function
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Job function
Engineering and Information Technology
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Director, Engineering and Reliability Services employer: Alkermes
Contact Detail:
Alkermes Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director, Engineering and Reliability Services
✨Tip Number 1
Network with professionals in the pharmaceutical and engineering sectors. Attend industry conferences or local meetups to connect with individuals who may have insights into Alkermes' culture and hiring practices.
✨Tip Number 2
Familiarise yourself with the latest trends in engineering and reliability services within the pharmaceutical industry. Being knowledgeable about current technologies and methodologies can help you stand out during discussions.
✨Tip Number 3
Prepare to discuss your leadership style and experiences in managing cross-functional teams. Alkermes values collaboration, so be ready to share examples of how you've successfully led diverse teams in past roles.
✨Tip Number 4
Research Alkermes' mission and values thoroughly. Understanding their commitment to neuroscience and patient care will allow you to align your responses with their goals during interviews.
We think you need these skills to ace Director, Engineering and Reliability Services
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in engineering and reliability services, particularly in pharmaceutical operations. Emphasise your leadership roles and any specific projects that align with the responsibilities outlined in the job description.
Craft a Compelling Cover Letter: In your cover letter, express your passion for the role and the company. Discuss how your background in chemical, electrical, or mechanical engineering, along with your extensive experience in facility operations, makes you a perfect fit for the Director position.
Showcase Relevant Skills: Highlight your knowledge of CGMP, FDA regulations, and your ability to lead cross-functional teams. Provide examples of how you've successfully implemented system improvements and operational excellence initiatives in previous roles.
Proofread and Edit: Before submitting your application, thoroughly proofread your documents. Ensure there are no grammatical errors or typos, as attention to detail is crucial in engineering roles. A polished application reflects your professionalism and commitment.
How to prepare for a job interview at Alkermes
✨Showcase Your Leadership Skills
As a Director, you'll need to demonstrate your ability to lead cross-functional teams. Prepare examples of past experiences where you've successfully managed diverse groups and achieved business objectives.
✨Understand the Technical Requirements
Familiarise yourself with the specific engineering knowledge required for the role, such as CGMP, FDA regulations, and facility systems. Be ready to discuss how your technical expertise aligns with the company's needs.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities in real-world situations. Think of scenarios where you had to troubleshoot equipment or implement system improvements, and be prepared to explain your thought process.
✨Emphasise Your Budget Management Experience
Since the role involves managing the Reliability Services budget, be prepared to discuss your experience with financial analysis and budget management. Highlight any successful cost-saving initiatives you've led in previous roles.
