Senior Manufacturing Equipment Engineer

Job ID: AMAGJP

Location: Thousand Oaks CA

Duration: 3 months (Possible extension)

This engineering position supports manufacturing activities associated with cGMP equipment and facilities at *** Thousand Oaks (ATO). The senior engineer works in partnership with the automation maintenance project management corporate engineering and manufacturing to develop and oversee the operation and reliability of equipment while driving safety and quality compliance. The engineer will support the department and capital projects and provide data to support business cases and long term strategy.

The Senior Engineer role will provide direct engineering technical support as follows:

Demonstrating role modeling of leadership behaviors and positive values to create a positive working environment.

Be individually accountable for manufacturing equipment reliability and deliverables on key capital projects to deliver business targets and deliverables

Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.

Suggest design modifications to address risks and design in quality and safety.

Develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (riskbased approach).

Oversee development of validation protocols in line with CQP Automation Systems Delivery SOPs and cGMP standards.

Recommend evaluate and manage performance of contract resources

Provide oversight for verification deliverables developed by outsourced/contract verification staff.

Act as a liaison between engineering and quality assurance during project planning execution and closeout

Ensure that work executed with safety compliant practices and documented in accordance with cGMP good documentation

Review and approve the commissioning reports maintenance practices and parts and drive productivity improvement

Related Activities:

Participate or lead when required multidisciplinary site teams e.g. cross functional team root cause analysis lead.

Support Lean Transformation and Excellence in Operations process improvement by leading supporting and documenting improvement opportunities to reduce cost improve safety/quality or improve speed.

Provide ad hoc technical support and guidance for manufacturing and maintenance

Provide coaching and guidance to project teams and engineers using riskbased approaches

Defend the equipmentspecific calibration maintenance & validation as required during regulatory inspections

Participate in internal audits and assess in conjunction with quality assurance

Assist in developing and maintaining business metric performance

Basic Qualifications

Doctorate degree OR Masters degree & 3 years of engineering and/or manufacturing experience OR Bachelors degree & 5 years of engineering and/or manufacturing experience OR Associates degree & 10 years of engineering and/or manufacturing experience OR High school diploma / GED & 12 years of engineering and/or manufacturing experience

Preferred Qualifications / Skills / Experience

Bachelors degree in engineering or another sciencerelated field

7 years of relevant work experience with 5 years experience in operations/manufacturing environment

Direct experience with regulated environments (FDA OSHA EPA etc.)

Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes clean utilities facilities instruments and equipment

Experience implementing riskbased verification on major GMP process equipment / automation projects including validation protocol development and execution

Understanding and awareness of industry/regulatory trends for verification/validation

Experience with combination product / medical device quality systems verification

Strong process equipment knowledge cell culture fermentation purification filling and packaging

Strong process automation knowledge understanding of automation infrastructure current technologies and automation project execution / verification.

o Knowledge of Delta V Rockwell and Plant Information Systems is a plus

Demonstrated strong communication and technical writing skills

Strengths in facilitation and collaboration / networking

Experience in developing SOPs and delivering training

Individual must be a team player prepared to work in and embrace a teambased culture that relies on collaboration for effective decisionmaking

Proven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA LEAN Six Sigma and fundamental understanding of statistics etc.)

Top 3 Must Have Skill Sets:

Looking for hands on engineer experience with proper training/ background in technical side/ mathematics. NOT LOOKING for quality lab/ bench top/ science work.

The job seeker needs to be practical with troubleshooting and be able to hold a technical conversation.

Industry background: Drug substance/ pharma / chemical/ oil refinery/ mechanical***********************************