Lead Engineer - facilities
Alkermes, Inc. is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression. Headquartered in Dublin, Ireland, Alkermes has an R&D center and US headquarters in Waltham, Massachusetts and manufacturing facilities in Athlone, Ireland, and Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.
Alkermes is seeking a highly motivated and experienced individual for the position of Lead Engineer - Facilities, at the Wilmington, OH location. Responsible for supporting the operation of the facility by assisting in troubleshooting/optimization of plant systems, designing and implementing OE initiatives, and implementing departmental capital projects such as upgrades to existing facilities and the installation of process and utility equipment to meet business requirements.
ESSENTIALS AREAS OF RESPONSIBILITY:
- Monitor and support all equipment operations of the facility
- Provide third tier support for troubleshooting of plant systems
- Represent department on project teams for large scale expansions.
- Develop, conduct and document test methods for facility systems troubleshooting and validations.
- Implement capital projects such as upgrades to existing facilities and the installation of process and utility equipment to meet business requirements
- Assist QA group with excursion investigations.
- Assist maintenance with facility systems operation, preventive maintenance, and specification and procurement of replacement equipment, spare parts and maintenance supplies.
- Write, review and approve operations and equipment SOPs.
- Assist with deviation determinations and final analysis.
- Assist in maintaining controlled CAD facility and systems drawings.
- Assist management with product scale-up, facility and product costs and facility modification and expansion considerations.
- Remain current on industry and FDA engineering standards and trends.
Minimum Education & Experience Requirements:
- BS in Chemical or Mechanical Engineering
- 5-10 years of industrial and/or pharmaceutical facility design, start-up and/or operations required;
- 10 years aseptic manufacturing, Oral Solid Dose or powder filling background preferred.
- Thorough mechanical 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.
- General knowledge of chemistry, statistics, facility design, cost estimation, process control.
- General knowledge of pharmaceutical operations and equipment validations, in-depth knowledge of facility and utility validations.
- Excellent communication and documentation skills.
- Ability to troubleshoot and maintain facility systems, equipment and processes.
- Excellent writing skills to prepare engineering and validation protocols, facility reports, summary documents, equipment specifications and SOPS.
- Ability to specify and size facility systems, equipment and process equipment.
- General knowledge base of Electrical, Instrumentation, Piping, HVAC, and Civil/Structural/Architectural disciplines
- Working knowledge of AutoCAD, Microsoft Project and Microsoft Office.
- Knowledge of OSHA and EPA facility requirements and regulations. Knowledge of pharmaceutical regulations such as FDA and MHRA is a plus.
- Knowledge of construction methods and procedures. Ability to understand/interpret engineering and construction drawings.
- Excellent people skills to supervise personnel and interact with other departments at all organizational levels.
Personal Attributes Needed:
- Excellent organizational skills.
- Ability to self-manage and prioritize workload.
- Ability to supervise a broad range of personnel.
- Ability to react quickly to understand and solve problems.
- Excellent troubleshooting skills.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.