Process Automation Engineer
311 Pennington Rocky Hill Rd Hopewell, NJ 08534 US
Job Description
Provide support to the Manufacturing team for in person FAT and SAT of the DCS system and process equipment (CIP, chromatography, viral filtration, and tangential flow filtration skids), Validation, and startup of new manufacturing facility at the Hopewell NJ Site.Â
Essential Functions of the job:
- Review and understand P&ID’s, General Arrangement drawings, functional specification documentation.
- Provide support and guidance in recipe design and testing.
- Generation of PIN charts from automation documentation
- Support validation during SAT/IQ/OQ
- Execute Test Protocols, Exception resolution and change controls.
- Train end-users
- As built documentation
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Core Competencies, Knowledge, and Skill Requirements
- Bachelor’s or above in Electrical Engineering, Chemical Engineering, or related Work experienceÂ
- Experience working in a FDA-regulated biotechnology or pharmaceutical company
- Experience in Automation, Electrical controls systems, instrumentation, and CSV
- Experience in equipment qualification and process validation, Supporting Greenfield Pharma plant startup.
- Experienced in Upstream and Downstream manufacturing processes in biopharmaceutical such as Filtration systems, Bioreactors, CIP, SIP, WFI system, Buffer Prep, Autoclaves and Biowaste systems. Strong communication skills (written and verbal).
- Experience using Studio 5000 Logix Designer, FTView SE & ME,, FTAssetCentre, WIN911 FTBatch, and PlantPAX / Delta-V
- Experience using TIA Portal and WinCC
- Rockwell / Siemens PLC, Drives
- OPC DA and UA Communication, OSI PI / Bio Reactors is desirable.
- Strong analytical and problem-solving ability.
- Hands-on approach, with a ‘can do’ attitude.
- Ability to prioritize, demonstrating good time management skills.
*Biopharma process experience required
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Computer Skills:Â Â Â
- Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)
- Ability to work on a computer for extended periods of time.
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Competencies:
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management - Communicates changes and progress; Completes projects on time and budget.
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