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.