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Manufacturing Operator 1 is the lowest position on the bio-pharmaceutical corporate ladder. I had a very different understanding of the job when hired. I quickly learned that engineer and operator are two different positions. However, from bellow, I had a quality view of a company structure ill-prepared for its needs. Commercial product demand outgrew the plant's capacity. A new manufacturing plant was under construction; which double the work force. Additionally, inter-departmental dialogue was non-existent. Training, although compliant, was generally unorganized and inadequate. Process Development (PD) and Engineering consistently introduced processes designed without realistic lab feasibility – i.e. equipment on the second floor is required for unprocessed product (~600Kg of liquid) collected on the first floor. Manual transport was available, but "manual" meant the two 135lb females. It wasn’t pretty. Consequently, process and operator errors skyrocketed. We were over-cramped, understaffed, overworked, and unprepared while production pushed forward regardless of lab conditions.
My lab was on day 4, hour 57 of a drug validation campaign. For a sixth time this campaign, a vital filter failed – a total loss of $70,000. I had recognized the error in the preparation procedure prior to product initiation. I was ignored. Instead, I was cited as the cause for this avoidable. My director threatened my job, assuming carelessness, and challenging my commitment. Three days later, PD released a memo correcting the procedural error I had highlighted weeks earlier. It took every clinical skill I possessed to maintain composure. I forced myself to listen through the anger and I started planning.
Over the following 48 hours, I observed communication styles, responsibility delegation, and where and when errors occurred. I wrote a performance report and designed a program to increase operator involvement and to improve overall plant efficiency....