Mgr, Engineering-Facilities Utility

Alkermes•Wilmington, OH

About The Position

Engineering leadership position for degreed Engineer/Manager with experience in pharmaceutical operations and knowledge of facility equipment/utilities. Position has responsibility for supervising/directing internal engineering resources, as well as contract service providers, to ensure business objectives are met and site facilities, utilities and equipment meet business requirements in a safe and compliant manner.

Requirements

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.
Ability to specify and size equipment systems and process equipment.
Excellent communication and documentation skills.
"Hands-on" ability to troubleshoot and install equipment.
Ability to troubleshoot and maintain facility/utility 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.
In-depth knowledge of internal change control and documentation control.
Strong customer service orientation.
Communication skills with technical professionals
Excellent organizational skills.
Positive management attitude.
Ability to self-manage and prioritize workload.
Ability to supervise and motivate a broad range of personnel to perform at a high level.
Ability to react quickly to understand and solve problems.
Fosters collaborative relationships within and across groups through influence and negotiation.
Excellent troubleshooting skills.
Skills and knowledge in Project Management
BS in Engineering required
Minimum of 10 years pharmaceutical production experience, to include six years related supervisory experience.
Demonstrated ability to motivate exempt and non-exempt employees and demonstrated management skills, (i.e., business knowledge, leadership, communication, ability to analyze technical issues, conflict resolution).
Thorough knowledge of cGMPs.
Experience in machine design, computer systems and instrumentation, validations, electrical power, and facility design and construction required.

Nice To Haves

Experience in the above plus cost analysis and pharmaceutical manufacturing validation experience preferred.

Responsibilities

Ensure engineering department resources are responsive and effective in meeting the tactical and strategic needs of the site.
Development and implementation of process and reliability improvement projects.
Provide oversight to relationships with key vendors, A&E firms and engineering service providers.
Ensure good project management practices are applied within department.
Assist maintenance and manufacturing with systems operation, preventive maintenance, and specification and procurement of replacement equipment, spare parts and maintenance supplies.
Engage with customers to ensure a high level of customer service.
Ensure interdepartmental teamwork to meet site objectives.
Develop staff with technological understanding, cross training and problem-solving techniques, to meet new business objectives and maximize team flexibility/capability.
Provide coaching/feedback to develop/enhance personnel capabilities.
Set and communicate clear standards/expectations of performance within the group.
Remain current on industry and engineering standards and trends.
Ensure that activities meet all regulatory standards. (e.g. FDA, MHRA, OSHA, EPA)
Monitor facility/utility overall operational robustness.
Identify, develop scope and estimates, and manage projects to completion for system improvements and operational excellence (OE) activities.
Assist MFG, RS and ES groups with deviations/investigations.
Oversee the development of Standard Operating Procedures for equipment and systems throughout the facility.
Write, review and approve design documents.
Review and approve C&Q documents.
Develop, conduct and document test methods for utility systems troubleshooting, commissioning and validation.
Participates in developing and integrating new technology/manufacturing innovations/new products that support the strategic goals of the business.
Assists Department to maintain effective operations.
Leads the development of area goals and objectives.
Manages implementation of goals and objectives as related to area.
Works closely with team, customers and Finance liaison in development of cost estimates; preparation of capital and expense budgets as related to area.
Monitors variances to financial, operating budgets and reports in timely manner.
Reviews and approves requisitions at approved level.
Provides timely, written and oral presentation to management of ongoing operating conditions, achievement of area goals and objectives, and variances versus administrative budgets/forecasts.
Supports in managing departmental programs.
Leads the development and implementation of performance measures and metrics throughout the area to measure success and to clarify expectations in all aspects of area operations.
Supports during inspections by FDA and other agencies and coordinates related.
Leads recruiting, interviewing, and selection of qualified candidates for open area positions.