PCI Pharma Services
|Company Name:||PCI Pharma Services|
|Job Location:||Bedford, NH|
|Job Posted Date:||20-04-2023|
PCI Pharma Services is seeking a Principal Plant Engineer 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 Principal Plant Engineer participates and assists other engineers in the design of packaging equipment or systems for optimal performance as well as works with manufacturing plants to improve overall equipment effectiveness. Provides Engineering support for Facilities, Equipment, Utilities, Capital Projects. The Principal Plant Engineer in collaboration with Engineering Management is responsible for technical oversight, review, and approval of the conceptual, basic, and detailed design, procurement, installation and start-up for new plant utilities, equipment, and systems. Leads Critical and Plant Engineering projects from inception to completion in collaboration with Engineering management. Performs economic analysis and feasibility studies for the installation of new equipment and/or modification and revision of existing equipment. Provides engineering mentoring to less experienced engineering personnel in collaboration with engineering management. This is a hands on highly active engineering role. JOB DUTIES – Supports safety through personal engagement and promote individual accountability for safety within the Engineering Department. Ensure risks to employee health and safety are rigidly controlled in compliance with the LSNE Environmental Health and Safety procedures. Develops cost estimates and scopes, reviews estimate and scopes with manager, and consults with manufacturing management regarding proposals for capital expenditures, repairs, and revisions. Investigates, develop, and recommend alternatives for design, procurement, and installation of new/modified equipment or systems for the optimal utilization and control of resources. Ensures inclusion of existing site and engineering team members in the learning process and design process for new plant systems. Systems include water pretreatment, generation of high Purity water, Chillers, Plant Steam, Clean Steam, Clean Air, Nitrogen, Plant HVAC, Fill Finish equipment and Freeze dryers. Leads the implementation of major capital projects as needed. Provide technical support through the gate process, during pre-construction phase, and coordinate daily activities with the production area and project management and contractors. Prepare URS, Risk Assessments, Safety Assessments associated with the project. Works with end users to develop system requirements, specification of equipment/buildings, review design from outside engineering firms or contractors (as needed), overseeing fabrication and leading Factory/Site Acceptance Testing. Works closely with other support groups such as MTS, Manufacturing, Quality Assurance, Facilities, Validation, EHS&S, and Quality to ensure that LSNE assets are well managed throughout their lifecycles. Provides system expertise for troubleshooting system failures, deviations, or unusual operations. Demonstrates an in-depth technical knowledge to support the manufacturing, and warehousing of pharmaceutical and biological products. Mentors junior Engineers by sharing information and providing feedback and guidance. Coordinates activities on minor capital projects working with project managers and department to implement the projects in a timely and safe manner and within the project budget and scope. Evaluates the feasibility of conceptual projects and prepares detailed analysis, including time and cost for completing the projects. Support all facets of production through involvement in process, reliability improvement projects, quality improvement projects and safety related projects. Participates in long-term strategic development of site Facilities, Systems, Utilities and Equipment. Support Capital projects. Demonstrate the ability to engage, motivate and positively influence others in the pursuit of achieving LSNE goals. PROFESSIONAL SKILLS – Strong organizational skills coupled with keen attention to details. Strong verbal and written communications skills. Interpersonal skills necessary to deal effectively and courteously with administrators, department heads, supervisors, employees, customers, representatives of governmental agencies, architects, engineers, contractors, vendors etc. Ability to prioritize, organize, and manage tasks and time effectively, strong project management skills. Proficiency with standard software applications, including MS Word, MS Excel, MS Project, MS Power Point. Knowledge of GMP and FDA regulatory requirements for drugs and/or medical devices. EXPERIENCE – Experience with aseptic liquid filling of vials, aseptic lyophilization filling of vials, and aseptic processes, including refrigerated and frozen capabilities a Plus. Experience with Control and Computerized Maintenance systems (CMMS), AutoCAD and SolidWorks, PLC a plus Experience working in a GMP and FDA regulatory environment for drugs and/or medical devices a plus. Knowledge and practical experience in using world class manufacturing, lean manufacturing, continuous improvement, and variation reduction techniques e.g. Six Sigma, DMAIC and FMEA tools. EDUCATION – BS or MS in Chemical, Mechanical, or other Engineering degree from an accredited university. A minimum of 10 years’ experience in engineering, facilities clean utilities and/or plant utilities, preferably in the biotechnology, medical device, or pharmaceutical industry. QUALITIES – Act as a champion and change agent in support of the Engineering Department and other continuous improvement efforts. Effectively support internal and external relationships, key stakeholders, vendors. Strong communication skills4 Possess a strong understanding of team and group dynamics. Excellent negotiator and leader who is a creative problem solver. Hands on and agility to working in a fast paced CMO environment. PHYSICAL REQUIREMENTS & MENTAL DEMANDS Must be able to gown appropriately and lift and/or move up to 50 pounds Must prioritize, organize, and successfully manage multiple assignments concurrently. Travel between facilities to carry out assignments COMMUNICATIONS & CONTACTS Interacts with and Works closely with Purchasing, Manufacturing, Quality, MTS, EH&S, Facilities, and Validation MANAGERIAL & SUPERVISORY RESPONSIBILITIES – Assigned Plant Engineers TRAVEL – less than 10%
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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Applicants must meet the above-mentioned requirements in order to qualify for consideration to work as a Principal Plant Engineer.
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