|Process Engineer II|
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
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.
The Process Engineer II ensures that all GMP Manufacturing processes are designed and executed in a compliant and efficient manner. The Process Engineer II is involved with the technical and regulatory aspects of all assigned projects from inception to completion. The Process Engineer II works cross-functionally within the entire organization to facilitate the successful development and completion of all projects, which ultimately meets the objectives and goals.
- Provide technical support to all GMP Manufacturing processes and project
- Develop manufacturing processes in conjunction with internal Formulation Development group, client or combination thereof, to enhance and improve the manufacture of GMP drug products.
- Write Master Batch Records and review executed batch records
- Write, review and approve Standard Operating Procedures (SOPs), specifications, and other procedures as required
- Recommend, specify and order GMP manufacturing equipment which includes setup, qualification, writing and execution of qualification protocols
- Process validation of commercial manufacturing processes including writing, review and execution of process validation protocols
- Participate in project scheduling (including daily, short term, and long term) activities along with all applicable departments
- Provide input for forecasting of budget requirements and help to manage department expenses
- Maintain a positive, professional and confidential relationship with sponsors
- Comply with all state and federal regulatory requirements and guidelines
- Oversee and direct maintenance personnel and workers engaged in equipment installation, facilities equipment repair and preventative maintenanc
- Formulate and coordinate program specifications, requirements for proposals and contracts and associated documents
- 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
- Stop work where deemed necessary to maintain safety
- 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 required (oral solid dosage experience desired)
- 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