Director I, Process/Specialty Engineer

Job Title Director I, Process/Specialty Eng

To be Considered Candidates:: Must be authorized to work in the country where the position is located.

Job Description The purpose of this position is to provide oversight for all Process Technology Engineering activities on large or key strategic projects in conformance with plans, specifications, schedules, and cost estimates. This role directs other line supervision to meet project objectives.

• Oversee the management of the Process Technology work activities
• Plan and execute process activities to complete client's process and engineering scope of work according to contract requirements
• Plan commissioning, startup, and activities as required by contract to meet target performance
• Act as the senior Process Technology program manager for client interface
• Support, participate in and/or lead Value Improvement Practices
• Support Project Management with risk management and the Business Risk Review process (Business Risk Management Framework – BRMF) particularly with respect to performance targets/ guarantees
• Other duties as assigned

Basic Job Requirements • Accredited four (4) year degree or global equivalent in engineering field of study and twenty (20) years of work-related experience; a recognized professional certification or registration in the applicable field, if required; some locations may have additional or different qualifications in order to comply with local requirements
• Ability to communicate effectively with audiences that include but are not limited to management, coworkers, clients, vendors, contractors, and other stakeholders
• Job related technical knowledge necessary to complete the job
• Ability to learn and apply knowledge of applicable local, state/province, and federal/national statutes and guidelines
• Ability to attend to detail and work in a time-conscious and time-effective manner

Other Job Requirements Experience in pharmaceutical industry, specifically with cell culture, purification, harvest downstream and upstream.
Hands on experience, with FAT or facility startup

Preferred Qualifications • Experienced with large scale bulk drug substance manufacturing of monoclonal antibodies and antibody like proteins.
• Experience with Cell Culture, harvest downstream, upstream, Protein Purification, Clean Utilities (WFI, Clean Steam, Clean gases, CIP/SIP design).
• Experience with small scale single use manufacturing of non-antibody proteins.
• Experience with single use mix systems, chromatography system, tangential flow filtration systems, viral filtration, and depth filtration.
• Experience with blood plasma products. Experience with plasma fractionation (centrifugation & filter presses), protein purification (both stainless steel and single use), formulation, fill & finish, ethanol recovery.
• Experience with small scale monoclonal antibody and antibody drug conjugate production (both drug substance and drug product.)
• Experience with handling cyotoxic materials
• Experience with cell & gene therapy.
• Experience with Life Sciences, Pharma or Biologics

Degree Required Yes
City (or Nearest City) Greenville
State/Province South Carolina
Country United States
Location Type Office