Manager, Reliability Services

Alkermes

17d•$120,000 - $140,000•Onsite

About The Position

The Manager of Reliability Services shall provide managerial support for all Building and Facilities systems located at the Waltham Facility. They will administer the design, planning, construction, and maintenance of equipment, machinery, and facilities systems. Plans, budgets, and schedules the full lifecycle services related to equipment installation, maintenance, modifications, and retirement including estimates on equipment, labor, materials, and other related costs. Oversees the coordination of building space allocation and layout, communication services, and facilities expansion. The role will be responsible for the maintenance team and select, develop, and evaluate its personnel to ensure the efficient operation of the function. The Manager of Reliability Services will work closely with Engineering, Office Services, IT, and operational groups to access systems requirements and develop solutions that meet all parties’ needs.

Requirements

Strong Mechanical and Chemical engineering background.
Familiarity with pharmaceutical critical utilities as well as knowledge of mechanical plant systems.
Ability to communicate with clients and create user requirements and corresponding detailed design specifications.
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 writing skills to prepare engineering and validation protocols, facility reports, summary documents, equipment specifications and SOPS, and batch records.
Strong hands-on mechanical and electrical aptitude to understand and troubleshoot the equipment and machinery with which our control systems interface.
Previous field engineering experiences a plus.
Ability to juggle multiple concurrent problems with supervisory direction.
Experience with MAXIMO or other Work Orders Management Systems (CMMS/EAM).
Ability to work full time onsite in our Waltham facility.
B.S./B.A. in science, engineering or relevant field and 10+ years related experience or Corresponding trade license with 15+ years’ experience.
5+ years expanded experience in the pharmaceutical /biopharmaceutical industry.

Nice To Haves

OSD experience desired.

Responsibilities

Manages, supervises, and coordinates the work of the facility team to ensure that the building and equipment is installed and maintained properly and on schedule to comply with good calibration/metrology/maintenance guidelines.
Team leadership role.
Develop a team driven department while working with Alkermes employees to understand issues and areas of need.
Establish clear goals and objectives with team collaboration.
Champion process and continuous improvement activities for the business process addressed by support systems.
Planning, development, and execution of maintenance programs and procedures for optimum benefit of Facilities and equipment.
Provision of administrative services, program coordination, long/short-range planning, and budgeting. (Small and Capital Projects, Space, Budget, Lease, SOPs, PM Programs)
Manage the associated budgets and service contracts.
Provide overall leadership and direction to the department (to include coaching team members, resolving conflict, reviewing performance, and initiating corrective actions.
Coordinate the specification, procurement, installation, and integration of equipment with the equipment owners, engineering, security, EHS and IT.
Perform analysis into cost-saving measures by grouping, spare parts and managed service.
Selection, installation, operation, maintenance, and modification of equipment and techniques required to provide a comfortable, safe, and healthy working environment.
Be a resource for facility related questions.
Assess breakdowns, systematically identify problems, and restore to operation.
Support Quality Assurance investigations, deviations, and audits.
Accurately review maintenance paperwork, including work orders and logbooks.
Review and update procedures based on field experience.
Review and update drawings to reflect as built conditions.
Identify opportunities for improving PM/Cal program.
Train on-site mechanics on technical details and procedures.
On-Call and Emergency Response.
Respond to a variety of problems that may and do occur.
Locate, determine, and correct problems or contact appropriate personnel for assistance.
On-Call duties responding to emergencies 24 Hours/Day.
On-Call rotation usually no more than once per month.