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Senior Process Engineer

Tampa, FL

Posted: 01/04/2023 Division: Life Sciences Job Number: JN -012023-16151

Job Description

Senior Process Engineer
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
  • Location: Tampa, FL (client on-site and not remote)
  • Industry: Pharmaceutical
  • Hours: M-F, 8am-5pm
  • Employment Type: Direct hire
Client overview
A global leader and trusted supplier in the pharma, biotech, and specialty ingredients markets. The company is focused on advanced manufacturing, high-quality control systems, regulatory expertise, and research and development (R&D) capabilities. The company s products and services include active pharmaceutical ingredients (API), stem cell therapies, drinking water sanitizers, vitamin B compounds, organic personal care ingredients, industrial preservatives and microbial control solution to combat viruses, bacteria and other dangerous pathogens.

Summary
The Senior Process Engineer provides daily management to Process and Validation Engineers. This leadership role ensures that all cGMP Manufacturing processes are designed and executed in a compliant and efficient manner. This role is intimately involved with the technical and regulatory aspects of all assigned projects from inception to completion. The Senior Process Engineer ensures that their department works cross the organization to facilitate the successful completion of all maintenance related projects to meet the objectives and goals

Key Accountabilities
  • Provide technical leadership and assign duties to Process and Validation Engineers within the reporting structure
  • Provide technical support to all GMP Oral Solid Dose (OSD) Manufacturing processes
  • Extensive knowledge in Blending, Granulation, Encapsulation, Tableting, Coating operations
  • Develop manufacturing processes with cross functional groups or clients to enhance and optimize overall production
  • Recommend, specify and order equipment and parts in support of specific projects including setup and qualification as well as writing and executing qualification protocols
  • Write Master Batch Records and review executed batch records
  • Write, review and approve SOPs, specifications and other procedure as required
  • Hire, train, develop and evaluate staff
  • Act as liaison to public utilities, environmental and energy agencies and assist in the inspection of construction activities to ensure conformance to specifications and suitability for occupancy
  • Analyze, inspect, plan and evaluate use of space and facilities including HVAC systems, computer network wiring lighting and other factors
  • Oversee coordination of building space allocation, layout and communication services
  • Oversee and direct maintenance personal and workers engaged in equipment installation, facilities equipment repair and preventative maintenance
  • Formulate and coordinate program specifications, requirements for proposals and contracts and associated documents
  • Attend applicable meetings, discussions, etc., in support of related projects
  • Maintain a positive, professional and confidential relationship with clients
  • Comply with all state and federal regulatory requirements and guidelines
  • Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclear
  • Promptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible

Qualifications
  • Bachelor of Science degree in Biological Sciences or Biomedical/Chemical Engineering. Masters of Science or Engineering or PhD highly preferred.
  • 5+ years of experience
  • Experience with Good Manufacturing Practice (GMP)
  • Pharma experience and Oral Solid dosage required
  • US/EU regulations and intermediate knowledge of statistical data analysis
  • Effectively presents information and ideas formally and informally, verbally and in writing to others in a manner that facilitates understanding.
  • Able to concisely communicate status, needs, forecasts, risks and timelines effectively to senior management
  • Excellent attention to detail, with ability to prioritize and be flexible in managing change, anticipating and resolving complex technical and business problems with ability to positively impact customer relationships and external technical network
EOE/ADA
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