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These strategies should be carefully aligned with the criticality of assets and the associated risks, ensuring that maintenance efforts are effectively prioritized and resources are utilized efficiently to prolong asset lifespan and reliability. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

The Sr. Manager, Fill & Finish, Pckg. & Inspection Production Engineering provides strategic leadership and governance for production engineering activities within pharmaceutical manufacturing operations. This role ensures safe, compliant, and efficient production by owning process engineering, equipment performance, and lifecycle management across isolators, vial filling, stoppering, and capping systems. The role leads and develops a team of Senior Production Engineers and Production Engineers, driving asset performance, risk-based decision-making, and continuous improvement. <ul><li>Role that this position reports to: Head of Reliability and Equipment Engineering</li><li>Role/s that report to this position: Sr. Production Engineers & Production Engineers</li></ul>Main Responsibilities and Accountabilities: List the roles and responsibilities of the position 1 Equipment Reliability & Operational Support <ul><li>Responsible for overseeing the reliability, availability, and performance of equipment in various production areas. This role involves implementing proactive measures to identify and mitigate risks that could impact GMP, safety standards, and the continuity of supply.  </li></ul><ul><li>Provide expert technical guidance for complex equipment issues, ensuring that the troubleshooting processes are systematic and methodical. Facilitate comprehensive root cause analysis to identify underlying problems and oversee the implementation of effective CAPA to resolve these issues and improve overall equipment reliability. Equipment includes, but is not limited to, vial washers, dehydrogenation tunnels, isolators, cappers, clean-in-place systems, clean-out-of-place systems, pasteurizers, and more. </li></ul><ul><li>Lead technical troubleshooting of complex deviations, sterility assurance issues, and equipment/process failures related to isolators and vial lines. </li></ul><ul><li>Establish and monitor reliability KPIs (e.g., MTBF, MTTR, maintenance effectiveness, OEE contributors) to drive continuous improvement. </li></ul>2 Maintenance & Asset Health Monitoring <ul><li>Supervise the creation and enhancement of maintenance strategies that focus on preventive, predictive, and condition-based approaches. These strategies should be carefully aligned with the criticality of assets and the associated risks, ensuring that maintenance efforts are effectively prioritized and resources are utilized efficiently to prolong asset lifespan and reliability. </li></ul><ul><li>Ensure effective use of CMMS data (SAP) to monitor asset health, maintenance trends, and lifecycle cost performance. </li></ul><ul><li>Champion predictive maintenance technologies and digital asset monitoring initiatives. </li></ul>3 Change Management & Continuous Improvement <ul><li>Govern equipment-related changes through formal change control processes, ensuring GMP compliance, risk assessment, and controlled implementation. </li></ul><ul><li>Lead and prioritize continuous improvement initiatives focused on asset reliability, compliance, cost optimization, and operational efficiency. </li></ul><ul><li>Ensure engineering standards, best practices, and procedures are established, maintained, and consistently applied. </li></ul>4 Asset Information & Lifecycle Management (ISO 55000 Alignment) <ul><li>Own and implement the site Asset Management Strategy in alignment with ISO 55000/55001, ensuring consistency with corporate asset management objectives. </li></ul><ul><li>Ensure asset lifecycle governance across design, operation, maintenance, modification, and retirement of manufacturing equipment. </li></ul><ul><li>Oversee asset information management systems, ensuring data integrity, traceability, and accuracy across engineering documentation, CMMS (SAP), and asset registers. </li></ul><ul><li>Ensure asset criticality assessments, risk priority scoring, and asset performance targets are defined, maintained, and actively used to support decision-making. </li></ul>5 Projects & Shutdown Support <ul><li>Accountable for the engineering portfolio of CapEx and OpEx equipment projects, including prioritization, resource allocation, and execution oversight. </li></ul><ul><li>Lead long-term asset lifecycle planning, including refurbishment, upgrade, and replacement strategies based on asset condition and business risk. </li></ul><ul><li>Provide leadership and governance for planned shutdowns, ensuring effective scope definition, execution, and post-shutdown performance review. </li></ul>6 Compliance, Quality & Safety <ul><li>Lead, coach, and develop Senior Production Engineers and Production Engineers, building technical capability in asset management, reliability engineering, and GMP compliance. </li></ul><ul><li>Set performance objectives aligned with asset management and operational goals and conduct regular performance and development reviews. </li></ul><ul><li>Foster a culture of ownership, accountability, continuous improvement, and cross-functional collaboration. </li></ul>7 People Leadership & Capability Development <ul><li>Lead, coach, and develop Senior Production Engineers and Production Engineers, building technical capability in asset management, reliability engineering, and GMP compliance. </li></ul><ul><li>Set performance objectives aligned with asset management and operational goals and conduct regular performance and development reviews. </li></ul><ul><li>Foster a culture of ownership, accountability, continuous improvement, and cross-functional collaboration. </li></ul>8Completes any other duties/responsibilities assigned by senior management  Position Qualifications and Experience Requirements:   Education  <ul><li>A bachelor’s degree in engineering (Chemical, Mechanical, Electrical) is required.  </li></ul><ul><li>Master’s preferred </li></ul>Experience <ul><li>7+ years of experience in pharmaceutical fill & finish manufacturing, with deep expertise in isolator-based aseptic processing and vial filling </li></ul><ul><li>3–5+ years leading engineers or technical teams </li></ul><ul><li>Experience in leading day-to-day decisions and personnel management. </li></ul><ul><li>Ability to successfully lead projects from start to finish, ensuring they are completed on time, within budget, and meet high standards of quality. </li></ul><ul><li>Strong understanding of GMP, validation, and regulatory expectations </li></ul><ul><li>Experience with reliability engineering, maintenance strategies, and CMMS systems </li></ul><ul><li>Knowledge of biotech manufacturing processes (upstream/downstream/fill-finish as applicable) </li></ul><ul><li>Familiarity with automation and digital systems </li></ul><ul><li>Strategic thinker with the ability to translate complex engineering challenges into actionable programs </li></ul><ul><li>Knowledge of Six Sigma/Lean principles is a plus. </li></ul> Competencies <ul><li>Strong analytical and problem-solving skills. </li></ul><ul><li>Excellent communication abilities. </li></ul><ul><li>Innovation Leadership </li></ul><ul><li>Technical Expertise in Asset Management </li></ul><ul><li>Data-Driven Decision Making </li></ul><ul><li>Change Leadership & Transformation </li></ul><ul><li>Cross-Cultural Collaboration </li></ul><ul><li>Commitment to CSL values, ethical behavior, inclusive teamwork, and modeling a positive, respectful culture. </li></ul>The expected base salary range for this position at hiring is $136,000- $171,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.<h2>About CSL Behring</h2>CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor  visit <a href="https://www.csl.com/" rel="nofollow noopener noreferrer" target="_blank">https://www.csl.com/</a> and CSL Plasma at <a href="https://www.cslplasma.com/" rel="nofollow noopener noreferrer" target="_blank">https://www.cslplasma.com/</a>. Our BenefitsFor more information on CSL benefits visit <a href="https://www.csl.com/careers/your-well-being" rel="nofollow noopener noreferrer" target="_blank">How CSL Supports Your Well-being | CSL</a>. You Belong at CSLAt CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging Equal Opportunity EmployerCSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit <a href="https://www.csl.com/accessibility-statement" rel="nofollow noopener noreferrer" target="_blank">https://www.csl.com/accessibility-statement</a>.

CSL Behring

Sr. Manager, Fill & Finish, Pckg. & Inspection Production Engineering

Asepsis

Asset Management

Automation

Best Practices

Biotech and Pharmaceutical

Budget Management

CIP (Clean-in-Place)

Capital Expenditure (CAPEX)

Cardiovascular

Change Control

Change Management

Chemical Engineering

Coaching

Communication Skills

Computerized Maintenance Management System (CMMS)

Continuous Improvement

Corrective and Preventative Action (CAPA) Systems

Cost Control

Cross-Functional

Data Quality

Decision Support

Documentation

Drug Manufacturing

Electricity

Emerging Technology

Establish Priorities

GMP (Good Manufacturing Practices)

Gene Therapy

Hematology

ISO (International Organization for Standardization)

Identify Issues

Immunology

Information Technology & Information Systems

Leadership

Lean Six Sigma

Maintain Compliance

Management Strategy

Manufacturing

Manufacturing Equipment

Manufacturing Operations

Manufacturing/Industrial Processes

Operational Expenditure (OPEX)

Operational Support

People Management

Performance Management

Performance Metrics

Performance Reviews

Plasma

Problem Solving Skills

Process Engineering

Process Improvement

Regulations

Reliability Engineering

Resource Management

Risk

Risk Analysis

Risk Management

Root Cause Analysis

Safety Standards

Team Player

Technical Leadership

Time Management

Traceability

Appcast PX 2

Certifications from a State Highway Agency or National Entity such as ACI (American Concrete Institute) or NICET (National Institute for Certification in Engineering Technologies) in earthwork, asphalt, and concrete if required by the client or jurisdiction in which they will be working. Work will require the knowledge of materials, methods, and equipment used in highway construction; knowledge of geometry and basic mathematics; ability to read, interpret and explain construction plans and drawings, contract provisions, and specifications; and communications ability.

42356BR Requisition ID: 42356BR Business Unit: TSU Job Description: CDM Smith’s Construction Engineering and Inspection (CEI) team is seeking a Senior Roadway and Bridge Construction Inspector for a dynamic, travel-intensive role. This position requires 100% travel to national project sites located east of the Mississippi River, offering a unique chance to work on impactful infrastructure projects in diverse outdoor environments. If you’re passionate about construction, enjoy being on the move, and thrive in field-based roles, this could be an exciting opportunity for you! Our Transportation Construction, Engineering and Inspection group assists in all levels of federal, public, private, and international organizations by offering construction services for transportation systems that reflect community needs. Our value-added program management, best-in-class design-build expertise, and unparalleled sustainability and economic solutions, build partnerships and create solutions for current and future environmental and infrastructure challenges. The CEI Senior Roadway and Bridge Construction Inspector will inspect and monitor construction activities at the project site(s). Inspector must be able to perform the most complex inspection activities for at least 2 of the 5 categories of construction inspection: 1) Roadway 2) Bridges 3) Drainage 4) Erosion & Control 5) Maintenance & Traffic. Candidate will work under limited supervision or direct supervision depending on demonstrated knowledge for the assignment. Work will require the knowledge of materials, methods, and equipment used in highway construction; knowledge of geometry and basic mathematics; ability to read, interpret and explain construction plans and drawings, contract provisions, and specifications; and communications ability. Primary Responsibilities:  Performing both complex and routine/standard inspections of construction to evaluate if appropriate materials and construction processes are used; and that construction conforms to plans, specifications, and special provisions.  Use higher-grade of equipment and perform complex calculations to perform construction inspection.  Review drawings to prepare for the construction inspection.  Understand the design of the construction that will be inspected. Document and communicate the results of the inspection, and communicate to the supervisor. Job Title: CEI Senior Roadway and Bridge Construction Inspector 1 Group: CEI Employment Type: Regular Minimum Qualifications: High School diploma or equivalent. Certifications from a State Highway Agency or National Entity such as ACI (American Concrete Institute) or NICET (National Institute for Certification in Engineering Technologies) in earthwork, asphalt, and concrete if required by the client or jurisdiction in which they will be working. Must possess a valid driver’s license. 8 years of related experience. Domestic and/or international travel may be required. The frequency of travel is contingent on specific duties, responsibilities, and the essential functions of the position, which may vary depending on workload and project demands. Equivalent additional directly related experience will be considered in lieu of a degree. EEO Statement: We attract the best people in the industry, supporting their efforts to learn and grow. We strive to create a challenging and progressive work environment. We provide career opportunities that span a variety of disciplines and geographic locations, with projects that our employees plan, design, build and operate as diverse as the needs of our clients. CDM Smith is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, pregnancy related conditions, childbirth and related medical conditions, sexual orientation, gender identity or gender expression), national origin, age, marital status, disability, veteran status, citizenship status, genetic information or any other characteristic protected by applicable law. Why CDM Smith?: Check out this video and find out why our team loves to work here! (https://www.cdmsmith.com/en/Video/Meet-CDM-Smith) Join Us! CDM Smith – where amazing career journeys unfold. Imagine a place committed to offering an unmatched employee experience. Where you work on projects that are meaningful to you. Where you play an active part in shaping your career journey. Where your co-workers are invested in you and your success. Where you are encouraged and supported to do your very best and given the tools and resources to do so. Where it’s a priority that the company takes good care of you and your family. Our employees are the heart of our company. As an employer of choice, our goal is to provide a challenging, progressive and inclusive work environment which fosters personal leadership, career growth and development for every employee. We value passionate individuals who challenge the norm, deliver world-class solutions and bring diverse perspectives. Join our team, and together we will make a difference and change the world. Job Site Location: United States - Nationwide Agency Disclaimer: All vendors must have a signed CDM Smith Placement Agreement from the CDM Smith Recruitment Center Manager to receive payment for your placement. Verbal or written commitments from any other member of the CDM Smith staff will not be considered binding terms. All unsolicited resumes sent to CDM Smith and any resume submitted to any employee outside of CDM Smith Recruiting Center Team (RCT) will be considered property of CDM Smith. CDM Smith will not be held liable to pay a placement fee. Amount of Travel Required: 20% Assignment Category: Fulltime-Regular Visa Sponsorship Available: No - We will not support sponsorship, i.e. H-1B or TN Visas for this position Skills and Abilities: Ability to communicate both verbally and in writing in English. Intermediate knowledge of mathematical functions including geometry and trigonometry. Intermediate knowledge of Microsoft Office Suite of applications (Word, Excel, Outlook, etc.). Ability to adapt to new technologies and quickly learn new computer, smartphone or related applications and programs. Advanced knowledge of materials, methods, and equipment used in highway construction. Ability to read, understand, interpret and explain construction plans and drawings, contract provisions, and specifications of basic to high complexity. Ability to lead and instruct more junior inspectors. Background Check and Drug Testing Information: CDM Smith Inc. and its divisions and subsidiaries (hereafter collectively referred to as “CDM Smith”) reserves the right to require background checks including criminal, employment, education, licensure, etc. as well as credit and motor vehicle when applicable for certain positions. In addition, CDM Smith may conduct drug testing for designated positions. Background checks are conducted after an offer of employment has been made in the United States. The timing of when background checks will be conducted on candidates for positions outside the United States will vary based on country statutory law but in no case, will the background check precede an interview. CDM Smith will conduct interviews of qualified individuals prior to requesting a criminal background check, and no job application submitted prior to such interview shall inquire into an applicant's criminal history. If this position is subject to a background check for any convictions related to its responsibilities and requirements, employment will be contingent upon successful completion of a background investigation including criminal history. Criminal history will not automatically disqualify a candidate. In addition, during employment individuals may be required by CDM Smith or a CDM Smith client to successfully complete additional background checks, including motor vehicle record as well as drug testing. Pay Range Minimum: $34.39 Pay Range Maximum: $56.74 Additional Compensation: All bonuses at CDM Smith are discretionary and may or may not apply to this position. Work Location Options: Successful candidate will be required to work 100% in the field locations. Driver's License Requirements: An appropriate and valid driver's license is required. Seeking candidates for a potential future opportunity!: We are looking for qualified candidates for this position in anticipation of future project opportunities. Please note this is an “Evergreen” position which will be used to build our candidate pool but is not a role that is open at this time. If you are interested in being considered for this position should this position become available, we encourage you to apply to be part of our talent community. By having your information on file, we can reach out to you when this or a similar role officially opens. Massachusetts Applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

CDM Smith

CEI Senior Roadway and Bridge Construction Inspector 1

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Sr. Manager, Fill & Finish, Pckg. & Inspection Production Engineering CSL Behring

CEI Senior Roadway and Bridge Construction Inspector 1 CDM Smith

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