Job Description
Assoc. Spclst, Engineering.
Responsibilities
Generation, review and approval of process documentation.
Execution of development and qualification studies across commercial and non-commercial product.
Representing Technical Operations department at cross functional meetings.
Development and qualification of new processes.
Qualification of new equipment where appropriate.
Lead & support investigations and troubleshooting of process studies as required.
Technical support for commercial manufacturing.
Technical support for new product introduction.
Ensure compliance with the QMS, industry/company specific standards and regulations.
Demonstrate effective communication and interpersonal skills.
Proactively act to consistently improve personal knowledge and capability.
Demonstrate an awareness of own capabilities and development needs.
Lead & support continuous improvement by active participation in, and contribution to, projects and problem-solving including use of production system processes and tools.
Application of technical knowledge to enable authoring of technical documents and technical decision making.
Support audit readiness, including preparation of story boards, ensuring GMP compliant documents are available, presentation to auditors as required.
Work collaboratively to drive a safe and compliant culture on site.
Participate in driving a high performing & inclusive culture, stimulating personal growth & development.
May be required to perform other duties as assigned.
Accountable for contribution to ensure that objectives are effectively achieved, consistent with company & regulatory requirements.
Respond to Operational and business areas, ensuring compliance with cGMP and company requirements.
Support continuous improvement by active participation in, and contribution to, projects and problem- solving including use of production system processes and tools.
Ensure that adequate processes and procedures are in place and followed for all relevant process activities.
Support business critical projects related to the Technical Operations department.
Provide technical support for cross functional programs & investigations.
Required Skills
Typical Minimum Education: Bachelor’s Degree; ideally in a Science, Engineering or other Technical discipline.
Proficiency in Microsoft Office and job related computer applications required.
Excellent communication, presentation and interpersonal skills.
Project management skills.
Flexible approach.
Effective time management and multi-tasking skills.
Excellent attention to detail.
Trouble shooting skills.
Goal/results oriented.
Demonstrable analytical and systematic problem solving skills.
Applied Engineering, Communication, Contractor Oversight, Driving Continuous Improvement, Engineering Standards, Equipment Qualification, Estimation and Planning, GMP Compliance, GMP Validation, Internal Audit Controls, Interpersonal Communication, Investigation Procedures, Lean Manufacturing, Manufacturing Quality Control, Manufacturing Scale-Up, Manufacturing Support, New Product Introduction Process, Process Control, Process Documentation, Process Optimization, Process Scale Up, Regulatory Requirements, Teamwork, Technology Operations, Writing Technical Documents.
Preferred Skills
Experience with industrial vaccines, biologics, and small molecule drug product manufacturing.
Knowledge of cGMP and regulatory requirements.
Strong analytical and problem‑solving ability.
We are an equal opportunity employer.
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