Job Description

Job Description

Job Description

PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.

At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals.

We are seeking an experienced Reliability Engineering Manager. Our ideal candidate is a versatile engineering professional, with superior skills and experience in the optimization of procedure improvement and a willingness to work in a dynamic, on-site pharmaceutical project environment.

Objectives of this Role:

• The System Owner will be responsible for ensuring the process and process equipment meet compliance, safety, and business requirements on a day-to-day basis, as well as respond to alarms, Out of Specs, Out of Tolerances, etc. to ensure product impact assessments are performed as necessary.
• Troubleshoot equipment to determine root cause of failure modes, own Corrective/Preventative Actions & associated change controls, provide input on preventative maintenance plans, assess change controls, and spearhead continuous improvement initiatives.
• Owns and maintains process equipment assets through CMMS (maintenance strategy, spare parts, WO workflow, CMMS Change Control assessment).
• Own quality records such as Change Controls, Deviations, and CAPAs related to manufacturing process equipment, and employ high quality technical writing within the required quality systems to ensure the manufacturing schedule is not impacted.
• Maintain Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment and update as required.
• Acting as an owner, provide engineering support for process equipment procurement and start-up and CQV at Moderna’s Norwood Clinical manufacturing facility (Experience with a Thermoforming, Heat Sealing, Plunger Insertion Side Loa and Top Load Cartoning, Flexible Packaging Line Design, Vision Inspection Systems, Serialization and on-line barcode printing and verification and coding)
• The System Owner will participate on project teams through all phases of engineering projects related to process equipment including development of user requirements, conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of facilities and/or equipment.
• Review design documentation from conceptual through detailed design, URS documents, and Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment and update as required.

Skills and Qualifications:

• A bachelor’s degree in Electrical or Mechanical Engineering or any other life science related technical field
• Minimum of 10 years relevant experience as a Process Engineer or System Owner in a Drug Product manufacturing environment.
• 10-15 years of experience in a GxP environment preferred.
• Experience with Drug Product technologies (Aseptic Filling Line for vials and Syringes, Filling Isolator, Formulation, Analytical Equipment, Automatic Inspection, Label and Secondary Packaging, Compounding and Component Prep equipment such as Parts Washer and Autoclave).

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