Engineering Project Manager
Company: Summit Biosciences
Posted on: April 8, 2021
The Engineering Project Manager is responsible for leading and
managing all phases of engineering capital projects including
conceptual design, budget development, scope development, detailed
design, procurement, schedule management, installation, start up
and qualification activities for strategic, troubleshooting, and
operational projects for the organization. This position is also
responsible for the development and/or technology transfer of new
solutions and modifications to our existing manufacturing process
systems to solve process problems, optimize equipment performance
and reliability and to manage related budgets and timelines.
- Lead projects to plan, organize, and manage activities to solve
process & production problems, develop and implement process
improvements, and implement new products into manufacturing while
maintaining the highest quality standards and facilitating
continuous improvement in product cost, asset utilization, cycle
times, and equipment reliability.
- Develop and lead strategic projects for process and plant
improvements to increase efficiency and drive down costs.
- Lead the design of facilities and equipment and the
optimization of existing manufacturing processes to deliver FDA
compliant production capacity on time and within budget.
- Lead qualification activities to assure facilities, utilities
and process equipment qualifications are performed to company
- Guide the specification and selection of manufacturing
equipment/utility equipment and award architectural and engineering
contracts based on comparative bids and analysis.
- Assist with planning and executing capital plan for facility
and production equipment related spending to assure production is
in a position to meet new product development and product launch
- Leads projects such as; new equipment design and procurement,
facility expansions, corporate level electronic systems.
- Responsible for understanding the process requirements and how
they impact equipment/utility/facility design.
- Communicate with partners and clients to identify and implement
any necessary equipment or capabilities for new projects.
- Plan, coordinate and track the progress of all project
- Assure compliance with quality policies and procedures related
to validation activities.
- Promote cooperation and teamwork with all departments by open,
candid communication and timely coordination.
- Develop and execute engineering strategic plan with key
elements including capacity, business continuity, technology,
profitability, asset utilization, etc.
- Help build a safety culture that strives for zero injuries
through engagement and a focus on prevention and strong safety
- Responsible for scope, schedule, and budget on engineering
- Author user requirement specifications.
- Author and track completion of change management.
- Assist in the development of the engineering strategic
plan/road map. Candidate Attributes
- Exceptional organizational skills and attention to detail
- Superior interpersonal and written communication skills and
demonstrated ability to effectively communicate with all levels of
- Extensive knowledge of cGMP regulations
- Must be flexible, adaptable, self-motivated and able to work
well independently and across teams and partners.
- Ability to clearly and concisely articulate constraints in a
quantifiable manner and identify alternatives to keep projects on
- Ability to influence and negotiate skillfully through tough
situations while maintaining good will and important
- Ability to work in a lean, action oriented organization and
demonstrate a strong work ethic.
- Ability to identify the need for and implement change while
inspiring confidence and enthusiasm within the team.
- Ability to provide innovative, compliant ideas or alternatives
that create value, including seeking new information and external
- BS in engineering or relevant technical discipline
- 10 years of experience in pharmaceutical engineering and/or
validation related functions
- Experience managing plant design, construction, commissioning,
and validation projects.
- Hands on experience in validation,
utility/mechanical/electrical equipment troubleshooting and repair,
and project management.
- Excellent knowledge of validation principles including
commissioning, IQ/OQ/PQs, Process validation, Cleaning validation,
Computer Related Systems validation, etc.
- Excellent working knowledge of cGMPs, OSHA compliance, HVAC
systems and cleanrooms, automated pharmaceutical processing and
plant utility equipment
- Excellent technical writing, communication, and organizational
- Experienced in financial and accounting principles/spreadsheets
and Project Management.
- Good interpersonal skills and the ability to work well in a
- Experience with MS project or related software.
Keywords: Summit Biosciences, Huntsville , Engineering Project Manager, Professions , Lexington, Alabama
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