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Engineering Manager

Overview

The engineering manager will report directly to a Director of MFG and will be primarily responsible for the design, deployment, and support of process and lab scale products used in the biopharmaceutical market. The successful candidate for this position should be an experienced engineer who has leadership and supervisory skills. Good understanding about production solutions, plays a strategic role in identifying opportunities & implementing technical solutions. You will also have responsibility for creation of new documentation and the maintenance of that documentation in an ISO regulated plant.  The successful candidate will actively work with personnel at all levels of within the organization and directly with external customers. 

 

Responsibilities

·        Provide technical leadership to a team comprised of electrical and mechanical engineering resources

·        Continually evolve the working practices within the team to improve efficiency and productivity when producing mechanical and electrical documentation

·        Develop and edit engineering design and manufacturing documents, technical evaluations, and regulatory testing at outside agencies to meet current standards.

·        Lead engineering design and validation projects, as well as provide support to manufacturing activities with any issues that arise.

·        Generate and execute necessary testing and qualification protocols as related to the overall design and performance of automated equipment

·        Design, develop, and implement hardware improvements to products

·        May provide training or presentations on basic functionality of hardware to field applications, service, and customers

·        Complete assigned work with minimal staff oversight

·        Communicate effectively with engineering staff and cross functional departments

·        Align with the Repligen’s EHS (Environmental Health & Safety) culture to foster a safe work environment and strive for continuous improvement.

·        Encourage support and participation in EHS activities and programs.

Qualifications

·        BS in an Engineering discipline with 5-7 years’ experience. 

·        Must have experience in leading engineering projects in a biopharmaceutical market space

·        2+ years of leadership experience – Managing professional and technical employees

·        Direct experience in a biopharmaceutical manufacturing facility is preferred

·        Experience leading a team in an ISO regulated company.

·        Advanced skills in electrical or mechanical engineering discipline from a design and development perspective.

·        Demonstrated knowledge of mechanical and electrical systems within an instrumentation and controls market.

·        Expertise in developing and editing engineering design documents, technical evaluations, and test plans for cGMP process equipment

·        Experience with Regulatory and Compliance, EMC, and Safety is preferred.

·        Strong written and verbal communication skills with ability to delegate tasks

·        Proficiency with standard business software is required (MS Office, etc.)

·        Able to interact with employees at all levels and cross functionally across multiple departments

·        Ability to demonstrate coaching and mentorship across multiple functions.

·        Lead by example and adhere to safety protocols, safe work practices, and PPE (Personal Protective Equipment) requirements.

Average salary estimate

$110000 / YEARLY (est.)
min
max
$90000K
$130000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Engineering Manager, Repligen

Are you an experienced engineer looking to take your career to the next level? Join Repligen as an Engineering Manager in Marlborough! In this pivotal role, you’ll report directly to the Director of MFG and be at the forefront of designing, deploying, and supporting leading-edge process and lab-scale products in the biopharmaceutical market. We’re on the lookout for a candidate who not only has robust engineering experience but also possesses strong leadership and supervisory skills. The ideal person will thrive in a fast-paced environment, eagerly identify opportunities for improvement, and implement smart technical solutions. Your responsibilities will include guiding a talented team of electrical and mechanical engineers, enhancing working practices for productivity and efficiency, developing critical engineering documentation, and leading validation projects to support our manufacturing needs. You will also interact with personnel at all levels, including external customers, making communication key. If you have a BS in Engineering and 5-7 years of relevant experience, including leadership in a biopharmaceutical setting, we want to hear from you! If you’re passionate about innovation, safety, and team building, Repligen is the place for you.

Frequently Asked Questions (FAQs) for Engineering Manager Role at Repligen
What are the key responsibilities of an Engineering Manager at Repligen?

The Engineering Manager at Repligen is responsible for providing technical leadership to a team of engineers, improving team productivity, developing engineering design documents, leading engineering projects, executing testing protocols, and supporting manufacturing activities. This role also involves ensuring compliance with ISO regulations and fostering a safe work environment.

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What qualifications do I need to become an Engineering Manager at Repligen?

To be considered for the Engineering Manager role at Repligen, you should have a BS in an Engineering discipline, 5-7 years of experience, and 2+ years in a leadership position within the biopharmaceutical sector. Direct experience in biopharmaceutical manufacturing and knowledge of mechanical and electrical systems is preferred.

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How does the Engineering Manager at Repligen interact with other departments?

The Engineering Manager at Repligen actively collaborates and communicates with cross-functional departments, engaging with personnel at all organizational levels. This interaction is crucial for aligning engineering efforts with overall production and operational goals.

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What skills are essential for success as an Engineering Manager at Repligen?

Essential skills for the Engineering Manager include advanced expertise in electrical or mechanical engineering, strong decision-making capabilities, proficiency in documentation practices under ISO regulations, and excellent written and verbal communication for effective team leadership.

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What is the work environment like for an Engineering Manager at Repligen?

The work environment at Repligen emphasizes collaboration, innovation, and safety. As an Engineering Manager, you will lead a team in a dynamic setting while adhering to safety protocols. Continuous improvement in working practices and active participation in EHS activities are integral to the culture.

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Common Interview Questions for Engineering Manager
Can you describe your experience leading engineering projects in the biopharmaceutical industry?

In your answer, highlight specific projects you have led, focusing on your leadership role, the challenges you faced, and the technical solutions implemented. Mention any tangible results or improvements in productivity or product quality.

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How do you ensure compliance with ISO regulations in engineering processes?

Discuss your understanding of ISO regulations and how you incorporate them into daily operations. Provide examples of how you have developed documentation and trained team members to adhere to these standards.

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What strategies do you use to manage a diverse engineering team effectively?

Talk about your approach to team leadership, focusing on communication, delegation, and mentorship. Highlight any specific actions you take to understand team dynamics and support professional development.

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Describe a time when you implemented a process improvement in engineering documentation.

Share a specific instance where you identified inefficiencies in documentation processes and the steps you took to improve them. Emphasize the positive outcomes and how it impacted team productivity.

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How do you address conflicts within your engineering team?

Explain your conflict resolution style, whether it's through direct communication, mediation, or fostering an open environment. Provide an example where your approach led to a positive resolution.

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What do you consider when developing engineering design and manufacturing documents?

Discuss the key factors you consider, such as clarity, compliance with industry standards, and usability of the documents. Provide examples of how thorough documentation has benefited projects you've managed.

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How do you keep up with the latest trends and technologies in the biopharmaceutical industry?

Share your methods for staying informed, whether through industry publications, networking with professionals, attending conferences, or ongoing education. Mention how this knowledge influences your work.

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Can you explain your approach to testing and qualification protocols?

Outline your method for developing and executing testing protocols, emphasizing attention to compliance, accuracy, and thoroughness. Provide insights into how you ensure that the protocols align with overall project goals.

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What role do you think safety plays in engineering management?

Discuss your philosophy on safety in engineering, including how it influences your decision-making and leadership. Provide examples of how you promote a safety culture within your team.

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What do you consider your greatest achievement as an engineering leader?

Reflect on your career and select an achievement that showcases your leadership abilities. Explain the context, your specific actions, and the positive impact it had on the team or organization.

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EMPLOYMENT TYPE
Full-time, on-site
DATE POSTED
April 11, 2025

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