Manager, Engineering - Process Equipment

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

Key Duties: 

• 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 production equipment 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 process equipment systems troubleshooting, commissioning and validation.
• Participates in developing and integrating new technology/manufacturing innovations/new products that support the strategic goals of the business.

Skills/Abilities: 

• Thorough mechanical and chemical engineering knowledge as it applies to drug product facility systems and production 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, in-depth knowledge of process 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 process 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.
• 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.

Personal Attributes:       

• 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

Education:

• BS in Engineering required

Experience: 

• 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, and pharma design and construction required.
• Experience in the above plus cost analysis and pharmaceutical manufacturing validation experience preferred.

About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023). 

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law.  Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Alkermes is an E-Verify employer.