Senior Engineer, Process Engineering (2nd3rdShift)

Member of the Engineering Team engaged in supporting all manufacturing processes and providing technical support to the Manufacturing Team. The Senior Engineer Process Engineering (shift) is responsible leading the equipment reliability program championing continuous improvement running capital projects and being the site expert on manufacturing process and systems. The role combines the benefit of small site (agile and broad responsibilities) with the structure knowledge and resources of a leading global pharmaceutical company. This is a senior level role where the engineer can assess current state issues develop plans initiate projects and drive execution to eliminate process and equipment issues/failures. This position is 5 days a week onsite aligned with the manufacturing shift operations (day swing or night) and may require after hours or weekend support as required.

Typical Accountabilities:

• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ. Code of Conduct and supporting Policies and Standards on time.

Report potential issues of non-compliance.

• Ensures compliance with AZ Corporate Policies and Directives. Site Standard Operating Procedures. Regulatory requirements and industry best practice (cGMPs GAMPITILPMI).
• Maintains a safe work environment and performs work in accordance with site Environment Health and Safety (SHE)
• policies and procedures.

Manufacturing Process SME

• Expertise in equipment and manufacturing process capability to support multiple process areas
• Leadership and project management skills; Lead executions of Manufacturing related engineering projects. Works on several different projects and prioritizes these projects with guidance
• Proficiency in all of the following disciplines equipment process/materials maintenance project delivery
• Lead investigations owns CAPAs and responsible or product impact assessment and risk assessments related to manufacturing processes.
• Lead troubleshooting activities to resolve critical escalations planned and unplanned activities and anticipate future engineering developments within maintenance/process area
• Designs studies executes experiments/protocols and perform data analysis. Develop and optimize processes within own area of process engineering.
• Track trend and analyse in-process data using statistical process control (SPC) methods. Monitor and improve process performance.
• Share technical knowledge and expertise with personnel in AstraZeneca to aid technical developments within the organization.
• Recommend and implement transformation/ continuous improvement initiatives within site with focus on cost saving and improvement of quality and efficiency.

• Employ Good Engineering Practices to streamline project executions
• Collaborates with cross-functional teams to solve problems
• Provide mentorship and coaching to junior engineers interns and manufacturing technicians
• Guide execution of processes (e.g. validation qualification operation evaluation and troubleshooting of process deviations) within process engineering area.
• Participate in communications with relevant internal teams (e.g. regulatory) for management of change control.
• Guide and track compliance of own work and work of others with SHE and other applicable standards and regulations. Provide engineering solutions to manufacturing challenges and meet all safety quality supply and requirements.
• Develop contacts across a range of departments and external groups acting as engineering representatives.
• Equipment Management:
• Prepare equipment for qualification activities including but not limited to: TOP preparation and review initial testing and qualification readiness
• Manages production equipment. Maintain equipment maintenance strategies and equipment lifecycle management
• Lead/ guide planning managing and monitoring of major manufacturing and maintenance plan projects from concepts to implementation
• Lead equipment specification design build commissioning and qualification to meet technical/safety/ and business

Essential Requirements:

• Entry-level Masters/ PhD degree in engineering science technology or related field (OR) Bachelors degree with 3 years of relevant experience.
• Experience working with procedures and compliance with GMP & SHE requirements.
• Experience managing process engineering processes (e.g. validation qualification operation) across PETs within a highly regulated environment.
• Experience in some of the following areas: new technology investigation process development capital project execution and sales product support.
• Experience working with digital tools and applications related to reporting documentation and analysis.
• Breadth of experience is a key requirement to establish credibility with key stakeholders. Preferably the following:
• Industry experience in a GMP environment
• Experience with spray-drying technology
• Experience with equipment maintenance
• Experience with regulatory inspections and handling deviations.
• Experience working within cross-functional teams.
• Has experience in change control budget and project management including a track record of driving continuous improvement initiatives
• Project management track record of delivering projects timely in-full and on-budget
• Technical role managing project aspects within a specialist area

Preferable Qualifications:

• Large Capital project management and execution experience
• Lean certification
• Experience with automatic process controls
• Root cause investigation training/ 6-simga
• TPM experience
• Data Analysis tools (SQL JMP Minitab) visual management tools (Powerbi PowerApps)
• Experience with spray-drying technology
• Experience in the following areas: Process scale up; validation activities for commercial production; feedstock and drying processes; and setting up new equipment (URS PID DQ IQ OQ PQ)

The annual base pay (or hourly rate of compensation) for this position ranges from $ 101643.20 - $ positions offer eligibility for various incentivesan opportunity to receive short-term incentive bonuses equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs paid time off (i.e. vacation holiday and leaves) as well as health dental and vision coverage in accordance with the terms of the applicable plans.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.