Veterans Preferred - Lead Automation Engineer

Company: GSK
Location: Rockville
Posted on: April 10, 2021

Job Description:

Military Veterans are Encouraged to Apply. Are you looking for an opportunity to analyze and develop solutions to engineering problems related to sophisticated biopharmaceutical manufacturing equipment and systems? - If so, this is the role for you.Demonstrate leadership skills and deal with constant changeAssign and prioritize all work requests for assigned area and oversee project execution to ensure requirements are met, timelines are met, customer needs are addressed and projects align with GSK goalsMaintain and manage assigned areas budgets, resource forecasting, and resource allocationEnsure all projects are compliant (cGMP, SOPs, OSHA, NFP, BOCA/IBC, Local and National Codes, etc.) and are executed with good engineering practiceDemonstrate good project management skills (schedule, cost, communications) and coordinate outside and internal resources to execute projects in a timely and cost-effective mannerEnsure a high level of compliance with cGMP and other regulatory requirements such as validation and BLA commitmentsMaintain and document all cGMP equipment/system modifications and upgrades through approved change control methodsProvide technical guidance and direction to establish specifications, operational parameters, and procedures for production and policy systemsSupport technology transfer and insource/outsource projects as neededSpecify process control equipment and instrumentation via engineering specificationsProvide technical content and support for the generation of validation protocols; such as, Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)Support/Interact with manufacturing/facility/lab/validation/quality groups to troubleshoot, optimize, test, and/or challenge equipment/systemsEvaluate resource requirements and provide resources as required in order to meet operational goalsPrepare, execute, and monitor staff development plans and administer performance evaluationsEnsure all engineer's training (Safety, cGMP, etc) is adequate and currentCommunicate concerns and issues of staff, project status, performance and suggestions for improvement to managementProvide 24/7 emergency support to ongoing manufacturing operationsPrepare and participate as needed in investigations and all audits by having a good knowledge of the systems and the facility and assuring all engineers understand their role in auditsParticipate in a sampling of L1 Self Inspections for the area(s) of responsibility.Develop and maintain user and administrative SOPs for applicable systems or department when requiredAdvanced working knowledge of biotechnology production and quality systems specifically cell culture and/or microbial processes. Commercial manufacturing experience is desired.Generate and maintain system life cycle documentation (Drawings, Design Files, URS, FRS, SDDS, etc) Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:Bachelor's Degree in Engineering7-10 years of relevant work experience in biopharmaceutical manufacturingAdvanced knowledge and systems expertise with DeltaV is required Preferred Qualifications: If you have the following characteristics, it would be a plus:Bachelors Degree in Chemical or Electrical EngineeringAllen-Bradley PLC's, GE Unicorn, OPC, Siemens Apogeee, and Syncade knowledge and experience is desiredKnowledge of regulatory requirements and drug development processAdvanced working knowledge of biotechnology production and quality systems specifically cell culture and/or microbial processes. Commercial manufacturing experience is desired.Well organized and able to multi-task in project environments, and skilled in technical communicationProject management experience Why GSK? Our values and expectations -are at the heart of everything we do and form an important part of our culture.These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.Continuously looking for opportunities to learn, build skills and share learning.Sustaining energy and well-beingBuilding strong relationships and collaboration, honest and open conversations.Budgeting and cost-consciousnessIf you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

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