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Operations Support Specialist


Castle Rock, CO 80104
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Job Details

Closing Date: X **16/02/18**


**General Information:**

**Job Title:**

**Operations Support Specialist**


**Vaccines Operating Unit**

**Position Reports to:**

**Operations Specialist**


**Job Purpose:**

Support operations within the OpU to ensure that the manufacture and disposition of product is carried out in an efficient and effective manner. The role encompasses several key activities that will vary depending on the key role assigned to each Operations Support Specialist. The Operations Support Specialist is responsible for ensuring support processes and systems are maintained and compliant.


**Job Responsibilities:** Core function responsibilities

+ Management of the Vaccines Safety Blueprint - in partnership with core EHS team

+ Co-ordinate overall IIF programs and including review and closure of business unit good saves

+ Project portfolio management - Owner/key facilitator of projects impacting Manufacturing Operations arising from Capacity Enhancement, Continuous Improvement/Lean Management system, Technical Process Improvements.

+ Manufacturing documentation - Control of documents such as SOPs, local books, logbooks and PBRs

+ MES Operations SME - Operations ownership for specific EBRs in partnership with Core MES support; responsible for CAPA implementation, project changes and troubleshooting issues escalated from Manufacturing Operations

+ Operational Excellence and Continuous Improvement SMEs

+ Co-ordinate & support audit readiness for the Operational Unit

+ Management/support for core meetings - Tech & Reg, Materials Review Board, MIND, Evolve, Investigations, Safety and Compliance, Hoishin, Good Practice Saves, Good Saves Review

+ Investigations, management & co-ordination of vendor / material issues - in partnership with GPO

+ Compliance and metrics management/reporting

+ Ownership for on-time delivery of Manufacturing Action Items relating to systems, materials, documentation

+ Complete/support ER/QARs in relation to own specific area i.e. MES, Materials, Environmental Monitoring

+ Champions program day partner

+ Generate Change controls and commitments as required for Ops Support

+ Engage with Right First Time Specialists

+ Development and Maintenance of Standard Work Production Plan

+ Long Term Capacity Planning



+ Third level Qualification in Science, Engineering or equivalent is preferred, though not essential.Exceptions may be considered where relevant skills/experience and correct attitude and behaviours exist (this may be supplemented by further education in parallel).

+ Ideally 4+ years of experience within a pharmaceutical manufacturing, Quality Assurance or Compliance environment.

+ Experience in operating within a regulated environment (EMEA, FDA)

+ Experience of business improvement or operations excellence projects.

+ Familiarity with Change control, investigation and Documentation Process in a manufacturing environment.

+ Experience of the specific biopharmaceutical process and the documentation related to that process.

+ Previous experience with an electronic document management system (e.g., PDocs/Documentum)

+ A good understanding of process manufacturing/computer systems

+ Experience of Production Planning and Resource Allocation.

+ Good interpersonal and communication skills.

+ An ability to deal with process change and implement new effective processes.

+ Ability to work individually with minimum supervision and as part of a team.

+ This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent. Incumbents may be asked to perform other duties as required.



+ Demonstrate the GC **OWNIT** ! values

+ Adhere to all HR Policies as appropriate

+ Personal Development plans focus on the 70:20:10 guidelines

+ CI tools/- capability is a key building block for learning & development - Trained and M1 certified.

+ Proactive engagement with key stakeholders.

+ Best practices developed and shared with other teams /sites.

+ Best practices actively sought and copied.

+ Proactive & effective communication within and across shifts

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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