Initially 12 months, with a chance to extend the contract if needed

This is an integrated contract development and manufacturing organization (CDMO) in the BioPharma industry offering specialized drug substances processing.

The Manufacturing unit Operations are only for the drug substance (Up Stream) processing, compounding, bulk packaging, in sterile, clean room environment.

Be part of the Engineering and Maintenance group. This role will report to the Sr. Manager of Automation

This person must be Proficient in DeltaV Batch configuration including phases, unit procedures, equipment modules, and control modules. Only DeltaV skills will not be considered.

The Contract Automation Engineer is responsible for configuration, programming, production support and project engineering of Emerson DCS DeltaV Batch

• B.S. degree in Engineering/Comp. Sc., or relevant technical field.
• General Automation experience with HMI, SCADA, DeltaV, DeltaV Batch, PLC, etc.
• hands-on experience with DeltaV Batch programming in the BioPharma industry.
• Familiarity with DeltaV Infrastructure.
• Excellent interpersonal and communication skills
• Ability to work independently with minimal supervision

• Experience managing DeltaV expansion projects
• Familiarity with IT /OT networks
• Familiarity with DeltaV Virtualization (Hyper-V, VMware)
• Strong understanding of ISA-88 batch control principles
• Experience supporting commissioning and qualification activities (IQ/OQ/PQ)
• Working knowledge of DeltaV Operate, Batch Executive, and Control Studio
• Understanding of DeltaV Historian, Diagnostics, and Alarm Management
• Experience integrating DeltaV with external systems such as MES or PI via OPC
• Ability to create and maintain documentation including SOPs, change requests, etc.

The Contract Validation Engineer coordinates and assists with all process and equipment changes and implementation of new systems, equipment, and product transfers.

The Engineer facilitates Process Development meetings, keeping track of validation projects and their status. The Validation Engineer researches new processes and suggests improvement for continued excellence and provides assistance on troubleshooting existing processes and equipment.

The Engineer participates in continuous improvement and Kaizen projects in support of the Quality System.

• Represents engineering and validation for new systems and equipment by providing technical information, writing, and review of URS documents.
• Supports engineering and validation efforts by performing FAT and SAT commissioning activities. Writes and executes protocols for qualification events.
• Apply general engineering principles to develop and implement capital projects that will reduce costs, improve operating efficiency, progress quality, and improve safety.
• Provide engineering support for new equipment upgrades and special projects.
• Develop project plans and schedules; estimate time and costs; track project progression.
• Report on project progress, limiting factors and issues, changes in project scope, develop contingency plans, and resolve issues impeding progress.
• Collaborate with production personnel to develop new projects, identify limiting factors in current projects, and create/maintain relationships.
• Assist Product Development with engineering support for new product lines.
• Comply with all company Environmental Health and Safety and Department of Health requirements.

• Bachelor’s degree in Engineering or related field
• Good people, communication skills to work in a team environment
• Experience with Sterile Aseptic Liquid Filling Operations in the Pharma Industry
• Ability to produce and present clear, concise, and professionally written communications and presentations.

• Master’s degree in Engineering or Technical field
• Experience in engineering, ISO execution, Quality Systems, commissioning, and qualification preferred and is used to determine job level (I-IV).
• Startup or Small company experience working in a dynamic and hands-on role.
• Contract Manufacturing experience working closely with customers and clients

• We are seeking a detail-oriented Senior Technical Writer with specialized expertise in sterility assurance to support the creation and management of GxP-compliant documentation.
• This role focuses on authoring and revising SOPs, validation protocols, environmental monitoring procedures, sterilization documentation, aseptic process simulations, and contamination control strategies.
• The writer will collaborate with SMEs across Quality, Microbiology, Manufacturing, and Validation to ensure documents are technically accurate, clear, and aligned with regulatory standards including FDA, EMA, ICH, ISO 14644, and Annex 1. Responsibilities include supporting regulatory inspections and audits by developing inspection-ready narratives and sterility assurance documentation.
• The ideal candidate has a strong background in microbiology or aseptic processing and experience writing within a regulated pharmaceutical or biotech environment.
• Proficiency with EDMS platforms such as Veeva Vault or MasterControl is highly preferred.
• The writer will also help maintain documentation templates and support continuous improvement efforts for sterility-related documentation. Strong writing, organizational, and cross-functional communication skills are essential for success in this role.

Technical Writing, Drafting Reports/Method Validation Protocols, Sterility Assurance, Microbiology, SOPs

• Bachelor of Science Degree in a STEM discipline (Science, Technology, Engineering, Math) of relevant technical experience
• Bachelor’s degree in the field of Mechanical Engineering is a Plus
• Strong writing skills and ability to work collaboratively to support and/or lead new growth efforts to improve instructional product process
• Experience with interpreting technical data from multiple sources and then using it to create accurate and high-quality instructional product

• Develop and execute validation and revalidation protocols for processes, equipment, utilities, and test systems.
• Develop and write Standard Operating Procedures for new processes and equipment.
• Support department projects by assisting engineers, calibrations, and validations on ongoing projects.
• Support internal and external audits by providing and/or presenting data appropriate to the investigation as required.
• Keep Department Management and personnel aware of Validation related issues that may have a regulatory compliance or financial impact.
• Ensure change controls, records, and procedures follow current Good Manufacturing Practices (cGMP) as well as Good Documentation Practices (GDPs).
• Review and write validation protocols, final reports, and summaries of work for release of equipment tested.
• Assist in the review of validation protocols for computer related systems, environmental monitoring, process validations and cleaning validations.
• Participate in the review of changes made under the Change Control System from a validation perspective
• Provide validation oversight to facility, utility and equipment upgrades • Provide validation input to technology transfers
• Read/interpret SOPs to ensure compliance 2
• Maintain up to date trainings
• Other duties as assigned Education and/or Experience:
• Bachelor’s degree in Science, Engineering, or relevant field
• Experience with validation requirements, preferred
• Experience with validation tools and processes, preferred

• Ability to troubleshoot and resolve technical issues on the manufacturing floor, including system commissioning, coordination with external suppliers, and addressing equipment alarms.
• Participation in continuous quality improvement initiatives in collaboration with cross-functional teams to drive operational excellence.
• Support for CAPA investigations by ensuring corrective measures are executed effectively and preventive strategies are sustainable
• Coordination with vendors and suppliers to commission new equipment, replacement parts, and ensure readiness for manufacturing integration.
• Conducting GxP and 21 CFR Part 11 compliance assessments to maintain validated, audit-ready systems.
• Development and authorship of training materials for technicians and operators to support knowledge transfer and compliance.
• Contribution to the improvement of production metrics such as yield, cycle time, and overall equipment effectiveness (OEE).
• Execution of risk-based assessments, including FMEA and hazard analysis, to identify and mitigate potential operational risks.
• Serving as a technical quality subject-matter resource for production lines, ensuring daily operations and performance enhancements align with compliance requirements.
• Creation and execution of equipment validation protocols (IQ/OQ/PQ) and development of studies to verify system performance
• Collaboration with engineering, production, and quality teams to align objectives and deliver validated outcomes
• Leveraging previously validated work to streamline new projects while driving process and documentation improvements.
• Preparation of test matrices and research methodologies to evaluate equipment reliability and performance.
• Authoring and maintenance of controlled documents, including SOPs, work instructions, and quality system records to ensure compliance and audit-readiness.
• Conducting data trending and statistical analysis on batch performance and equipment efficiency to identify patterns and root causes
• Developing structured comparison reports for equipment evaluations and change control processes to support engineering decisions.
• Reviewing and revising vendor documentation, including supplier qualifications and warranty information, prior to validation.
• Ensuring compliance with legal and ethical standards during non-conformance reviews and validation activities involving critcal systems.
• Partnering with global suppliers and contract manufacturers to review technical specifications and integration strategies.
• Supporting the introduction of new technologies into manufacturing while ensuring compliance with internal standards and regulatory requirements
• Planning, coordinating, and managing validation activities, ensuring audit-readiness and on-time delivery.
• Supporting multiple projects by managing timelines, achieving milestones, and delivering validation-related outcomes.
• Executing computer system validation (CSV) for database-driven applications used in manufacturing, with a focus on data integrity and compliance
• Leading installation, integration, and validation of automation systems, including Programmable Logic Controllers (PLC) and Human Machine Interaces (HMI).
• Programming PLCs using Studio 5000 and developing HMI interfaces with FactoryTalk to support production needs.
• Ensuring ongoing validation and requalification of GMP systems in alignment with compliance requirements.
• Designing and implementing secure systems to handle validated data and user access controls.
• Authoring system-level validation documentation, including compliance protocols and reports.

• Bachelors in Computer, Mechanical , Pharma , Industrial Engineering or related feild .
• Validation: IQ, OQ, PQ and TMVs
• Automation control systems – PLCs, HMIs, Vision systems, Servos & Robots.
• Familiarity with standard MS Office tools.
• Good verbal and written communication skills.