BS in Science, Engineering, or technical related field.
Five 5 years of experience in Engineering Department related matters in the biopharmaceutical industry.
Knowledge of EOHSS, cGMP’s, local/Federal regulatory requirements, and documentation procedures pertaining to a biopharmaceutical manufacturing plant.
Timely and effective decision making, and timely conflicts resolution skills.
Computer literate with the ability to understand and use basic computer software packages like Excel, Word, Power Point, Internet, etc.
Ability to read and interpret layout drawings, mechanical, pneumatic and electrical blueprints, is preferred
Fluently in English/Spanish (Oral and Written)
Strong interpersonal relationship skills with subordinates, peers, management and clients.
Strong Technical Writing Skills to prepare trends analysis, investigation reports and regulatory and internal audits responses.
In-depth knowledge in the design, installation, commissioning and validation/qualification of equipment/instruments as applied to pharmaceutical production environment.
Experience with external and internal regulatory audits (DNRA, JCA, FDA, EMEA, etc.)
Good technical writing skills and ability to review SOPs and work instructions
Self-motivated, creative and team work oriented.
Self starter and good organizing and planning skills
Strong knowledge and experience in statistical tools
Strong presentation skills
Able to interact effectively with people to establish and maintain excellent working relationship with internal and external customers’ at all organizational levels and disciplines in such a way to facilitate the engineering department work.
Self-starter and able to plan and prioritize multiple complex activities simultaneously (i.e.: installation, integration, commissioning and validations/qualifications, timelines, etc.) by using sound Project Management Skills.
Willing to work irregular hours, different shifts, weekends and holidays, when necessary
Owns the Engineering department Technical (Production and Facility Equipment), Lean Strategy and Compliance Services related to EOHSS and Sustainability Non-Capital projects, CAPA, Audits, Change Controls and Environmental Activities.
Including CAPAs, non capital projects and any improvements activities related to this program.Monitors the change process for system procedures and standards.
Evaluates change proposals, coordinates change development, and implements change.
Advises on and participates in the training of the EOHSS users.
Establish a system to ensure work requests/orders are accurate and clear, the validity and accuracy of information and that the appropriate resources to set a preliminary priority are engaged.
Measures and monitors backlog for adherence to site and SOP standards.Write deviations to document and investigate atypical events in the Engineering related to EOHSS and any other Sustainability Non-Capital projects, CAPA, Audits, Change Controls and Environmental activities.
Lead investigations as necessary.
- Acknowledge, conducts and/or approve investigations for the engineering department activities.
Lead and / or develop Corrective Actions and Preventive Actions (CAPA) or Actions related to regulatory observations, internal audits or deviations. Perform the EOHSS CAPA management of the Engineering department.
Provides technical assistance and oversight to the Engineering Technical Services workflow management procedures and adherence to established KPIs.
Supports readiness of the facility for Regulatory Inspection.
Leads and represents the engineering department during regulatory agencies inspections such as FDA, DNRA, JCA and Health Agency and/or during internal company audits.
Support Engineering Department with EOHSS Agreements discussion and approvals.
Collaborates with other departments such as Quality, EOHSS, Manufacturing Technology, Production and Planning and scheduling to ensure alignment of goals.
Prepares, submit and discuss reports of Engineering Department Technical Services areas status for trending and evaluation to the site management.Assures that site complies with Corporate Systems by evaluating, implementing and enforcing the company policies and guidelines.
Prepares the Engineering Department presentation and manage the action items from the monthly EOHSS Council meeting and presentations.
Develops impact assessments related to Policies and Directives implementation.
Ensures corporate policies and directives are implemented in a timely fashion, following pre-establish schedule.
Support the Inspection Readiness Program.
Provides support to Site Projects.
Provides compliance oversight and verifying compliance with BMS Policies, guidelines and regulations
Liaison for regulatory initiativesCreates, evaluates, follows up and approves GMP Change controls and EOHSS MOC for the Engineering Department, including interaction with corporate support areas.
Enforces critical analytical thinking in the Change Control and Deviation management process.
Provides guidance on gaps identified from the review and actively participates to determine potential remediation activities.
Participates in Tier Meetings, department staff, planning and change control board meetings as required.
Maintains communication with internal and external customers to ensure compliance and timely completion of the assigned activities.
Provides leadership and direction for the implementation of strategic projects aimed at fostering a Culture of Excellence and other strategic initiatives, (Engineering 6S program sustainability, Tiers Management System maintenance & sustainability, and the deployment of operational excellence tools) to increase capabilities and performance in collaboration with the site operational excellence team.
Leverages operational excellence toolset using techniques to analyze core Engineering Operational areas influenced by process improvement, new systems infrastructure, and waste reduction.
Participates actively in the preparation of the department budget and effectively manages company funds and actives.
Creates business cases using operational excellence tools, coach, and manage operational excellence projects to ensure continuous process improvements and waste reduction with measurable financial results.
Performs other duties as assigned, like assistance in supervision and technical support of other Engineering Department section like Production maintenance, Facility / Utility and Capital projects sections.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
