Sr Engineer

Echo Consulting Group Inc; Puerto Rico; Hybrid; USD 110,000 - 150,000; Full time

Job summary

Cencora is seeking a dedicated engineer for on-site, fixed-term work in Juncos, PR, to optimize manufacturing processes and support capital projects. You will independently characterize strategies, design experiments, and implement major system modifications while coordinating with cross-functional teams.

Responsibilities include change controls, investigations, CAPAs, risk assessments, and on-floor troubleshooting. A strong pharma/biotech background is required.

Qualifications

• Knowledge of pharma/biotech processes and GMP/GLP requirements.
• Experience with validation and regulatory documentation in a controlled environment.
• Ability to operate specialized laboratory equipment and related computer systems.
• Strong problem solving and technical reporting abilities.

Responsibilities

• Own and support change controls for manufacturing process changes.
• Lead investigations, root cause analyses and CAPA activities.
• Support risk assessments and microbial evaluations; participate in campaign readiness.
• Develop training materials and provide on-floor troubleshooting and guidance.

Skills

Pharma/biotech processes

Validation processes

Regulated documentation

Lab equipment operation

GLPs and GMPs

Engineering in production

Problem solving

Technical report writing

Verbal communication

Validation protocol execution

Education

Doctorate

Masters + 2 years engineering experience

Bachelors in Engineering + 4 years engineering experience

Job description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere.

Job Details Summary of Role: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity Responsibilities: Own change controls for manufacturing process changes Support major/trend deviation investigations throughout the whole lifecycle including Root Cause Analysis investigation, determination of Corrective/Preventive Actions, authoring process investigation reports, and presenting within regulatory inspections. Support Risk Assessments exercises and Microbial assessment evaluations. Led commercial campaign readiness and effectively communicate and collaborate with cross function areas. Assist in the generation of training materials and assist in providing training on scientific or technical aspects of the process. Provide commercial support when needed and assist on the floor troubleshooting. Design, coordinate, and support execution of functional tests, water tests, and other runs to challenge process and operations during major changes, or campaign readiness. Generate technical protocols as needed. Assist and provide guidance during MBR (Master Batch Record) creation/revisions. Perform assessment to support process, automation, or equipment modification or implementation of special projects Initiate, revise, and approve standard manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner. Assess process performance and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities. Complete assessments for CAPA applicability requests from other plants/sites Complete assessment for new or changes in BOM's (Bill of Materials) Serves as a peer-recognized specialist in at least one area, with overall responsibility for determining methodologies in that area. Shift: Administrative Location: Juncos, PR Education: Doctorate OR Masters + 2 years of Engineering experience ORBachelors in Engineering + 4 years of Engineering experience Preferred Qualifications: Manufacturing Equipment ownership at CMMS system (Work orders approval, closing, PM strategy, spare parts' definition/accuracy/updates), reliability and change control assessments and requirements. Collaborate with Engineering Staff to ensure the best maintenance strategy on manufacturing equipment operations. Responsible for enhancing system reliability focusing on equipment availability, downtime reduction and maintenance optimization Develop equipment performance metrics (availability, downtime, etc.) with emphasis on identifying equipment performance improvement opportunities. Lead the implementation of equipment improvements projects SME (Subject Matter Expert) for systems regarding design, maintenance and point of contact during compliance operations. Support equipment troubleshooting within the functional area or in the scope of technical expertise. Support deviation process and define, Implement and own CAPAs associated to equipment within area of expertise Drives Environmental, Health and Safety compliance within the organization Skills: Working knowledge of pharmaceutical/biotech processes Familiarity with validation processes Familiarity with documentation in a highly regulated environment Ability to operate specialized laboratory equipment and computers as appropriate. Ability to interpret and apply GLPs and GMPs. Ability to apply engineering science to production. Able to develop solutions to routine technical problems of limited scope Problem solving and applied engineering. Basic technical report writing Verbal communication Comprehensive understanding of validation protocol execution requirements. This position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility.

What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora

Full time Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [e-mail]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Affiliated Companies Affiliated Companies: Echo Consulting Group Inc

Cencora is a leading global pharmaceutical solutions company that is committed to improving the lives of people and animals everywhere. We connect manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them. We’re a purpose-driven organization, where all of our team members around the world are united in our responsibility to create healthier futures. We work together every day to help our partners bring their innovations to patients worldwide, creating unparalleled access and impact at the center of health.