Senior Manager, Engineering | PCI Pharma Services Careers

Job’s Overview:

PCI Pharma Services is seeking a Senior Manager, Engineering in Bedford, NH. Please take a moment to read the job post below if you are interested:

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

JOB SUMMARY- The Senior Engineering Manager leads long range planning activities for Plant Engineering events in collaboration with Engineering leadership to develop and implement strategic Engineering and capital plans aligned with the company’s business strategy inclusive of equipment design and upgrades. The Senior Engineering Manager will ensure the Engineering department’s readiness to support production and plant engineering activities and works in concert with the Quality and EH&S Management System. The Senior Engineering manager must possess proven abilities and passion for developing, mentoring, and leading a multifunctional Plant Engineering team, with a focus on change management. The Senior Engineering Manager partners and works in partnership with other enablement functions e.g. Development, Project management, Operations, Facilities, Validation, MTS, Finance, Purchasing, QA etc. JOB DUTIES- Provide strategic management, coaching, and performance management of the Plant Engineering team members. Lead the Engineering team in supporting the site’s commercial production and new product introduction; fixture and equipment needs for aseptic manufacturing processes such as the fill/finish of drug product and drug substance, medical devices. Coordinate with cross functional stakeholders on equipment roadmap for manufacturing lines. Manage team of Plant engineers with varying levels of experience and to develop and build the team’s strengths and skillsets. Use performance metrics to ensure proper operations and drive continuous improvement. Partner with cross functional teams to lead manufacturing improvements internally and at contract manufacturers. Identify best practices and industry standards for Plant Engineering, Equipment Design and Development, and assists with Maintenance Programs. Implement a valued add mindset and culture to drive continuous improvement based on lean principles Ensure continuous execution of engineering related operations within the plants in compliance with quality, safety, and environmental standards. Oversee and review requests from other groups, executing on plans and delivering on objectives related to plant manufacturing needs. Support compliance audits and quality systems. In collaboration with engineering leadership, plan, and direct multiple complex projects with the accountability for successful completion of all project deliverables within established schedule, scope, and quality and safety. Lead in identifying risk, developing mitigation strategies, defining alternative solutions, and resolving issues in collaboration with cross-functional groups. Negotiate plans, budgets and schedules relating to facility modifications, facilities or equipment maintenance, expansions, upgrades and/or new construction for multiple areas. Lead efforts to optimize equipment, and asset management processes and systems by assessing business needs and developing, proposing, and implementing technology solution options. EXPERIENCE- Six (6) plus years of progressive managerial experience with no less than 5 years at the managerial level. Proficient in all aspects of unit operations including formulation, fill and finish, Lyophilizers and packaging and labeling in a GMP environment. Knowledge of filling line barrier isolation technology is important. Experience managing budgets for large and small capital projects. Demonstrable experience on project teams for cGMP capital projects is required, as well as participating in client and regulatory audits while utilizing tact and patience in providing requested information. PROFESSIONAL SKILLS- Excellent oral and written communication skills required. Proficient in Microsoft Office including Word, Excel, Power Point, Project. Ability to make independent sound decisions and independently manage priorities in alignment with department and site drivers. Must be detail oriented with ability to multi-task and strong focus on safety, quality, and attention to detail. Ability to demonstrate initiative and confidence coupled with the ability to plan, manage work in an efficientmanner. Strong understanding of the science/engineering of manufacturing platforms in biopharmaceuticals. Highly developed analytical skills, detail oriented and excellent problem solving/troubleshooting skills. EDUCATION- BS or MS in Chemical or Mechanical or Engineering discipline is required with 10+ years of GMP/Biopharma industry experience. Extensive knowledge in aseptic processing and lyophilization are preferred. Knowledge of GMPs, 21CFR, and other international regulatory requirements and guidelines. QUALITIES- Proactive mindset to assist Plants in site improvements, reliability engineering, cost reduction, and sustainability. Ability to influence cross functional senior management to ensure project success. Results oriented and results driven and accustomed to working in a dynamic Biopharma CMO environment. Excellent customer service skills, Professional and collaborative team player with good interpersonal skills. PHYSICAL REQUIREMENTS & MENTAL DEMANDS- Must be able to stand for long periods of time each day. Travel and work at all LSNE site locations/Facilities. Ability to successfully prioritize and multi-task with competing demands and at times shifting priorities. Able to don ISO cleanroom gowning and PPE, as required by site procedures. COMMUNICATIONS & CONTACTS – Interacts with all department staff to resolve technical issues and initiate process improvements. Must be able to work with multiple departments including Manufacturing, MTS, Validation, Facilities, Quality Control and QA MANAGERIAL & SUPERVISORY RESPONSIBILITIES- Manage up to 10 Direct/Indirect Reports TRAVEL – Approximately 5%

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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